Wound or skin treatment devices with variable edge geometries

ABSTRACT

Devices, kits and methods described herein are provided for treatment to skin, including but not limited to wound healing, the treatment, amelioration, and/or prevention of scars or keloids. A book-like packaging, applicator and/or tensioning device can be used to apply a dressing to a subject. The packaging, applicator and/or tensioning device applies and/or maintain a strain in an elastic dressing, and include undulating edge configurations to reduce peak stresses applied to the skin compared to traditional dressing shapes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to U.S. application Ser. No. 13/345,524,filed on Jan. 6, 1012, U.S. Provisional Application Ser. No. 61/430,908,filed on Jan. 7, 2011, U.S. Provisional Application Ser. No. 61/443,647,Filed on Feb. 16, 2011, U.S. application Ser. No. 12/854,859, filed onAug. 11, 2010, and U.S. application Ser. No. 11/888,978, filed on Aug.3, 2007, all of which are hereby incorporated by reference in theirentirety.

BACKGROUND

Scar formation in response to cutaneous injury is part of the naturalwound healing process. Wound healing is a lengthy and continuousprocess, although it is typically recognized as occurring in stages. Theprocess begins immediately after injury, with an inflammatory stage.During this stage, which typically lasts from two days to one week(depending on the wound), damaged tissues and foreign matter are removedfrom the wound. The proliferative stage occurs at a time after theinflammatory stage and is characterized by fibroblast proliferation andcollagen and proteoglycan production. It is during the proliferativestage that the extracellular matrix is synthesized in order to providestructural integrity to the wound. The proliferative stage usually lastsabout four days to several weeks, depending on the nature of the wound,and it is during this stage when hypertrophic scars usually form. Thelast stage is called the remodeling stage. During the remodeling stage,the previously constructed and randomly organized matrix is remodeledinto an organized structure that is highly cross-linked and aligned toincrease mechanical strength.

While the histological features characterizing hypertrophic scars havebeen well documented, the underlying pathophysiology is not well known.Hypertrophic scars are a side effect of excessive wound healing, andgenerally result in the overproduction of cells, collagen, andproteoglycans. Typically, these scars are raised and are characterizedby the random distribution of tissue bundles. The appearance (i.e.,size, shape, and color) of these scars varies depending on the part ofthe body in which they form, and the underlying ethnicity of the personaffected. Hypertrophic scars are very common, and may occur followingany full thickness injury to the skin. Recently, it has been shown inU.S. Patent Application Publication 2006/0037091 (U.S. patentapplication Ser. No. 11/135,992 entitled “Method for ProducingHypertrophic Scarring Animal Model for Identification of Agents forPrevention and Treatment of Human Hypertrophic Scarring,” filed May 24,2005) which is hereby incorporated by reference in its entirety, thatmechanical stress may increase hypertrophic scarring in a murine model.

Keloids are typically characterized as tumors consisting of highlyhyperplastic masses that occur in the dermis and adjacent subcutaneoustissue in susceptible individuals, most commonly following trauma.Keloids are often more severe than hypertrophic scars, since they tendto invade normal adjacent tissue, while hypertrophic scars tend toremain confined within the original scar border.

BRIEF SUMMARY

Devices, kits and methods described herein may be for treatment of asubject at a skin site including without limitation for wound treatmentor the treatment, amelioration, or prevention of scars and/or keloids,by manipulating mechanical or physical properties of skin or byshielding skin from stresses, and/or by controllably stressing orstraining the epidermis and layers of dermal tissue at or near a skinsite, i.e., at or adjacent a wound or a treatment site of a subject'sskin. According to variations, manipulating mechanical or physicalproperties may thereby modulate tensile or compressive stress at theskin site. The stress at the skin site may be reduced to levels belowthat experienced by normal skin and tissue. The stress at the skin sitemay be increased to levels above that experienced by normal skin andtissue. The stress or strain may be applied to surrounding tissue inone, two, or more directions to manipulate endogenous or exogenousstress at the skin site in one, two or more directions. According tovariations, devices and methods described herein may reduce or otherwisemanipulate the stress experienced by skin and/or a wound and surroundingtissues in order to treat a subject. The devices may also assist inpreventing or reducing the incidence of wound dehiscence.

According to the devices, kits and methods described herein, a skintreatment device, skin device, wound treatment device, scar or keloidtreatment device, scar or keloid amelioration or prevention device,bandage, or dressing may be provided that may be applied, attached to orcoupled to one or more layers of the skin or tissue of a subject(hereinafter referred to as “dressing”, “skin device” or “skin treatmentdevice”).

In addition to amelioration of scar formation, other uses for such skintreatment device may or may not include without limitation, for example,treating skin related conditions such as acne, blemishes, rosacea,warts, rashes (including but not limited to erythematous, macular,papular and/or bullous conditions), psoriasis, skinirritation/sensitivity, allodynia, telangiectasia, port wine stains andother arterio-venous malformations, and ectopic dermatitis; treating orimproving existing scars, wrinkles, stretch marks, loose or sagging skinor other skin irregularities; lifting, pinning, holding, moving skin forvarious purposes such as during pre-operative preparation, duringsurgical procedures for example as a low-profile tissue retractor, tostabilize blood vessels during needle or catheter insertion,postoperatively, pre or post operatively for pre-treating orpreconditioning skin for example, prior to scar revision, woundincision, body contouring, in mastectomy skin expansion, aesthetic skintreatment or resurfacing whether topical or subdermal, whether or notusing an energy modality such as, for example, microwave,radio-frequency ablation, high-intensity focused ultrasound, laser,Infrared, incoherent light, during weight loss, or for aestheticpurposes; hair removal or hair loss; treating and/or closing skininjuries for example, incisions, wounds, chronic wounds, bed sores,ulcers (including venous stasis ulcers), preventing or reducing theincidence of wound dehiscence, diabetic skin or wound conditions, burnhealing and/or relief; acting as an occlusive or negative-pressure wounddressing; protecting incisions or wounds, e.g. prevention of splittingor opening, protecting newborn belly buttons after cutting umbilicalcord. Such treatments may include use of a drug or other therapeuticagent that may be applied to the skin with such device. The agents mayinclude but are not limited to antibiotics, antifungals, immunemodulators including corticosteroids and non-steroidal immunemodulators. The agents may be provided in any of a variety offormulations, including but not limited powders, gels, lotions, creams,pastes, suspensions, etc. The devices may also be used for purposes ofdelivering a drug to the skin or through the skin, for example bystretching the skin and applying a drug thereto. Differentconfigurations of the device may be amenable to the size or geometry ofdifferent body regions. The treatments may be applied to regions of anyshape (e.g. linear, curved, stellate), size or depth, and to one or moreregions of the body, including but not limited to the scalp, forehead,face (e.g. nose, eyelid, cheeks, lips, chin), ears, neck, shoulder,upper arm, lower arm, palm, dorsum of the hand, fingers, nailbed,axilla, chest, nipple, areola, back, abdomen, inguinal region, buttocks,perineal region, labia, penis, scrotum, thigh, lower leg, plantarsurface of the foot, dorsal surface of the foot, and/or toes. Suchdevices may also be referred to herein as a “dressing”, “skin device” or“skin treatment device”.

In some situations, an immediate, quick or simple application of adressing may be desired. Devices, kits and methods described herein maybe for the preparation and/or application of a dressing to the skin andthe separation of the applicator, tensioning device or dressing carrier,support or base from the skin device.

The devices, kits or methods described herein may include a packaging,carrier, support, base, applicator or tensioning device, each of whichmay: contain, hold, carry or support a dressing at least temporarily;may be used to prepare a dressing for application; may be used todeliver, orient or apply a dressing; may be used to maintain a dressingin a stressed or strained configuration; may be used to stress or straina dressing; may be used to separate the dressing from the packaging,carrier, support, base, applicator or tensioning device and/or may beused during or after application of a dressing to provide additionaltreatment to a wound, incision or other treatment location; and/or maybe used to apply pressure to a wound, incision or other treatmentlocation. According to some variations, a packaging and/or applicatormay provide structural support for a dressing while or after an adhesiveliner is released. According to some variations, the assembly may beconstructed to avoid folding or bending of the dressing to the extentthat the adhesive on the dressing sticks to itself. For example, whensome variations of the dressing are held or supported at one point oralong one edge of the dressing in a cantilever configuration, thedressings will not bow, laterally deform, or otherwise deform out ofplane, under their own mass or configuration.

In some other variations of the devices and methods herein, a devicewith a substantially rigid support structure or that provides structuralsupport to a dressing and that provides a particular resistance tobending or column strength when two opposing edges of the device andsupport structure are placed under a compressive load that causes axialcompression or lateral deformation, e.g. a force similar to a handgrasping force is applied to an edge of the device, before the devicebuckles or folds. For example, a resistance to bending may becharacterized as the peak force that is achieve as the device andsupport structure are compressed without compressed by 25% of itsoriginal dimension. This column strength or rigidity may vary, dependingupon the direction along the device and support structure beingmeasured. In some further variations, the peak force may be at leastabout 0.02 Newtons per millimeter (N/mm), about 0.03 N/mm, about 0.05N/mm, about 0.1 N/mm, about 0.15 N/mm, about 0.2 N/mm, about 0.3 N/mm,about 0.4 N/mm or about 0.5 N/mm. In some variations of devicescomprising generally flat or planar devices and support structureshaving a thickness, the peak force may be measured by applying acompressive force along the shortest dimension of the device/supportstructure that is transverse to the thickness of the device/supportstructure. According to such variations, the device may have an aspectratio of length to width that is greater than 1:1, 2:1 or 3:1, forexample.

A resistance to bending in the direction of dressing strain may also bemeasured by three-point bending, applying a transverse force to themidpoint of the applicator simply supported on two outer points at agiven distance apart or support span. For example, the distance betweenthe two points of a sample may be approximately 0.75 inches and a forcethat ranges from about 1 to 1.25 pounds may be applied to a sampleapproximately 0.35 inches in width resulting in a deflection ofapproximately 0.05 inches. A resistance to bending may also be measuredby characterizing the force at which buckling occurs on a simplysupported beam. For example, a force of approximately 0.45 pounds may beapplied to a simply supported sample approximately 0.35 inches in widthand may result in a deflection of approximately 0.004 inches. Theresistance to bending may also be characterized by the strain of theouter surface before fracture or permanent deformation. By takingmeasurements of the support structure and the deflections during thetest procedure, a load deflection curve may be generated and theflexural modulus of the support structure may also be calculated. Insome variations, the support structure may comprise a flexural modulusof at least about 0.9 GPa, while in other embodiments, the flexuralmodulus is at least about 1 GPa, at least about 1.1 GPa, at least about1.2 GPa, at least about 1.3 GPa, or at least about 1.4 GPa.

In another example, a device of 7 cm wide by 19 cm long may beconfigured with a support structure comprising a paperboard, supportsheet or support structure. The support structure may have an averagethickness in the range of about 0.008″ to about 0.028″ or greater. Insome specific variations, the support structure may have a thickness ofabout 0.012″, about 0.016″, about 0.018″, about 0.024″, about 0.28″ orabout 0.032″, about 0.036″, about 0.04″, about 0.05″ or greater. Uponthe application of force along the lengthwise edge of the 19 centimeterlength, i.e. across the 7 cm width of the device, the support structuremay provide sufficient rigidity or column strength to achieve peakforces of about 3 pound or more, 4 pounds or more, or of about 10 poundsor more, while being compressed, collapsed, bowed, buckled or otherwisedeformed by 25% along its 7 cm width (i.e. about 1.75 cm). In somevariations, the support structure may comprise scoring or regions ofreduced thickness to permit some bending it at least one direction or inboth directions.

According to some variations, a device that provides structural supportmay have a plurality or supporting cross elements or segments extendingfrom one edge of the length to an opposing edge or the length (or fromone edge of a width to an opposing edge of a width); According to somevariations there may be three or more cross elements, e.g., a crosselement extending along two opposing edges and transversely across awidth (or a length) and one or more cross elements extending across thewidth (or length) and between the cross elements along the two opposingedges. Such cross elements may or may not be coupled or connected toeach other, for example, with a relatively flexible material. Such crosselements may have a total aggregate width with respect to the length ofan opposing edge of about 20% or more, about 25% or more, about 30% ormore, or about 35% or more. According to some variations, one or morecross elements may be provided that have a total aggregate width,relative to the length of the opposing side, between about 20% to 100%.Such cross elements may be segmented and may provide flexibility whenbending in a direction and rigidity relative to the flexibility, inanother direction.

The packaging and/or applicator may also provide structural support orstability of the dressing as it is oriented and/or applied to the skinof a subject. According to some variations, the dressing and packagingis configured to be pre-oriented in a position facing a wound before orafter the wound device is prepared for application, e.g., the adhesiveliner is removed. According to some variations, the packaging orapplicator is configured to be used with one hand to orient and/or applythe device to the skin of a subject. For example, in some situations,particularly where a longer or larger dressing is used, a packaging orapplicator provides structural support for a dressing such that a usercan effectively hold onto, manipulate and/or apply a prepared dressingwith one-hand. According to some variations, the assembly comprises asupport structure. A dressing support structure is defined herein tomean a structure that is coupled whether directly or indirectly, to aback surface of a dressing that is to be applied to a subject. Thesupport structure may further comprise at least in part, a material orstructure that is more rigid than the dressing to be applied to asubject. The support structure may comprise one or more elements orsegments. It may be constructed of a single substrate, a laminate or aplurality of elements coupled together and/or to the dressing. Accordingto some variations at least 20%, 25%, 30%, 35%, or 40% of a length orwidth of the dressing is supported by one or more support structuresextending from a first opposing side to an opposite side along a lengthor width of the dressing. In some further variations, the percentage ofa length or width that is supported by the support structure(s) is aminimum average of support across the entire length or entire width ofthe device, e.g. at least a 20%, 25%, 30%, 35% or 40% average supportacross an entire dimension of the device, e.g. length or width.According to some variations, an entire area of a dressing is supportedby a support structure. According to some variations, a base, carrier orsupport of a dressing may comprise at least three support structuresextending transversely between opposing sides of the dressing. Accordingto some variations, a support structure comprises interconnected membersor elements. According to some variations, a base, carrier or supportremains coupled to the dressing as it is applied. According to somevariations, greater structural support is provided to a dressingcarrier, support or base in a first direction while greater flexibilityis provided in a second direction, while lesser flexibility is in thefirst direction and lesser structural support is provided in the seconddirection. According to some variations, one or more support structuresmay extend beyond an edge of the first opposing side. According to somevariations, one or more support structures, at least in part, may extendbeyond at least a portion of an edge of a first opposing side and atleast in part beyond at least a portion of an edge of an opposite side.According to some variations, a support structure may extend at least 3mm from at least a portion of an edge of the dressing. According to somevariations, the packaging or applicator is configured to improve asterile transfer of a dressing to a wound of a subject. According tovariations, the packaging or applicator may be sufficiently wider orlonger, or have a sufficiently larger area than a dressing providing theability to maneuver or manipulate the support or applicator so that itprovides sterile application and/or one-handed application without theneed to touch the dressing. According to some variations, a margin ofdistance is provided from the outer edges of the dressing carrier,support or base to the dressing supported on the base or adhesive on thedressing. Such margins may be selected to prevent or resist a user fromtouching the dressing or dressing adhesive when grasping the edges tomanipulate the dressing carrier, support, applicator or base.

Devices, kits and methods described herein may be for the treatment,amelioration, or prevention of scars and/or keloids by creating and/ormaintaining a predetermined strain in an elastic skin treatment devicethat is then affixed to the skin surface using skin adhesives totransfer a generally planar (e.g. compressive) force from the bandage tothe skin surface.

In some variations, a dressing is provided, comprising an elastic sheetstructure (e.g., a comprising a silicone polyurethane, TPE(thermoplastic elastomers), synthetic rubber or co-polyester material)comprising an upper surface, a lower surface, a first edge and a secondedge opposite the first edge, and one or more adhesive regions. Thedressing may further comprise a first release liner releasably attachedto the adhesive region or regions. The adhesive region(s) may comprise apressure sensitive adhesive. The dressing may be tapered or otherwiseshaped to reduce skin tension at the edges. The dressing may havemodified, reduced or no adhesive near its edges to reduce skin tensionat the edges. Portions of the dressing may be unstrained and may therebyreduce strain in certain areas of the skin where the dressing isapplied. In some specific examples, the unstrained area or areas arefound between the edges of the dressing and the strained area(s). Insome further examples, the unstrained areas are limited to this area andare not found, during application or use, between the strained areas ofa single dressing, in use. In still further examples, the unstrainedareas are limited to areas along the edges of a dressing that intersectthe strain axis of the strained area(s), but not to areas along theedges of the dressing that are generally parallel to the strain axis.

A packaging device, dressing carrier, dressing support, dressing base,applicator and/or tensioning device may be provided. The packagingdevice, dressing carrier, dressing support, dressing base, applicatorand/or tensioning device may be configured to stress and/or strain adressing prior to application to a subject. A device may be used tostrain and/or maintain a strain on a dressing. In one variation, adressing is provided, comprising a first device attachment structure,zone or region, a second device attachment structure, zone or region,and a structure or mechanism configured to exert a separation forcebetween the first and second device attachment structures, zones orregions. The device may further comprise a releasable locking mechanism,attachment mechanism or adhesive, configured to maintain the member ormechanism in a strained configuration.

In some situations, application of a compressive force to a wound isdesirable to reduce bleeding. According to some variations, thepackaging, carrier, support, base, applicator or tensioning devicedescribed herein may be further used to help reduce bleeding, e.g., byallowing application of a compressive force using the device while orafter the dressing is applied. A coagulative additive may also beprovided on a dressing.

According to one aspect, the packaging, carrier, support, base,applicator and/or tensioning device may be sufficiently rigid orsupportive in at least one direction, to hold a dressing's form so thatit is easy to manipulate.

According to some variations, the packaging is also sufficientlyflexible in at least one direction to permit curving or shaping of thedressing to conform to the curvature or shape of the location on thebody or skin where the dressing is applied. Generally, the flexibilityof the packaging used to conform the dressing to the treatment site maybe configured so that the treatment site is not substantially deformedduring the application of the dressing; so that the application of thedressing is relatively smooth or uniform on the skin; and/or provides auniform, predetermined, or relatively predictable strain or force to anarea of skin The packaging or applicator may have flexibility in a firstdirection and greater rigidity in another direction. The packaging orapplicator may include elements or segments that permit flexibility withrespect to adjacent elements or segments.

According to some variations, the packaging is also sufficientlyflexible in at least one direction to permit curving or shaping of thedressing to conform to the curvature or shape of the location on thebody or skin where the dressing is applied. Generally, the flexibilityof the packaging used to conform the dressing to the treatment site maybe configured so that the treatment site is not substantially deformedduring the application of the dressing; and/or so that the applicationof the dressing is relatively smooth or uniform on the skin; and/orprovides a uniform, predetermined, or relatively predictable strainand/or force to an area of skin. The packaging or applicator may haveflexibility in a first direction and greater rigidity in a seconddirection. The first direction may be transverse to the direction ofstraining or have a component that is transverse to the direction ofstraining. The second direction may by the direction of straining orhave a component that is in the direction of straining. The firstdirection may or may not be transverse with respect to the seconddirection. The packaging or applicator may include elements or segmentsthat permit flexibility with respect to adjacent elements or segments.

According to some variations a desired flexibility, for example havingat least one component transverse to the direction of straining, may becharacterized by a modified cantilevered beam bending model, i.e.applying a force to the free end of a beam, simply supported from theother end, while wrapping it around a cylindrical object with a knownradius of curvature or curvature, defined as the reciprocal of theradius of the curvature. According to one variation, the force to bendthe packaging or applicator around an object with a predeterminedcurvature may be no greater than about 3 pounds. According to onevariation, the force may be no greater than about 0.3 pounds. Accordingto one variation, the force to bend around a predetermined curvature ofabout a 2.5 inch radius may be no greater than about 3 pounds. Inanother variation, the force to bend around a predetermined curvature ofabout a 2.5 inch radius may be no greater than about 0.3 pounds.

According to some variations, a packaging, applicator or tensioningdevice is provided comprising a base having an inner surface to which adressing is removably attached, and a cover or lid having an innersurface interfacing the inner surface of the base when in an initialclosed configuration. According to some variations, the base and coverare coupled at corresponding edges along their corresponding lengths toform a book-like structure whereby the cover may be rotated with respectto the base to open the device. Alternatively the cover may be liftedoff of the base. According to variations, a liner is attached to thecover and will expose an adhesive side of a dressing when the cover islifted or opened.

In some variations, the book-like structure, in the closedconfiguration, comprises a layered structure comprising a cover/lid, atreatment device and a base, in that relative order, while in the openconfiguration, the relative order of the layered structure changes to acover/lid, a base, and a treatment device. The treatment device may alsocomprise one or more release layers. In one variation, in the closedconfiguration, a first face of the cover/lid is in contact with a firstface of the treatment device, and a first face of the base is in contactwith the second surface of the treatment device opposite the firstsurface, while in the open configuration, a second face of the cover/lid(opposite the first face of the cover/lid) is in contact with a secondface of the base (opposite the first face of the base) but not with thefirst face of the treatment device. In some variations, the cover/lidmay be separated from the base during or after tensioning of thetreatment device. In some variations, the treatment device may beattached asymmetrically to the book-like structure, relative to thebending region of the book-like structure. In some instances, theasymmetric attachment may provide the user with a mechanical advantagewhen tensioning the dressing, and/or may reduce manufacturing costs byoptimizing the amount of elastic material used in the dressing. In othervariations, the dressing or skin treatment device may be attachedsymmetrically to the book-like structure, relative to the bending regionof the book-like structure.

In another embodiment, a method of applying a dressing to a surface isprovided. According to some variations the method may comprise providinga dressing packaging comprising: an applicator comprising a basestructure having an inner surface and a manipulation portion; a dressingcomprising a first surface configured to be applied to a skin or woundof a subject; and a back surface, wherein the back surface of thedressing is removably coupled or anchored to the inner surface of thebase structure, and wherein the first surface faces away from the innersurface of the base structure; and a cover configured to removably coverthe first surface of the dressing. A method may further compriseremoving the cover to expose a first surface of a dressing; and usingthe manipulation portion of the base structure to apply the firstsurface of the dressing to a wound or skin of a subject. In anothervariation, a method for treating a wound is provided, comprisingstraining an inner region of an elastic bandage between a firstunstrained region and a second unstrained region, and attaching at leastthe strained inner region of the dressing to a skin site or bothstrained and unstrained regions.

According to some variations, a dressing packaging assembly comprises: abase structure having an inner surface; a cover structure having anopposing surface, wherein the base structure is movably coupled to thecover structure; and a dressing comprising a first surface configured tobe applied to a wound or skin of a subject, and a back surface, whereinat least a portion of the back surface is removably coupled to the innersurface of the base structure; and wherein the cover structure isconfigured to move from a first position where the opposing surfaceinterfaces with and is substantially parallel to the first surface tothe dressing to a second position where the opposing surface isseparated from the first surface of the dressing. According tovariations, the first surface of the dressing comprises an adhesiveregion. According to variations the first surface of the dressingcomprises an adhesive backing interfacing an adhesive region on thedressing. According to variations, the opposing surface of the coverstructure comprises an adhesive backing covering the adhesive regionwhen the cover structure is in the first position and separated from theadhesive region when the cover structure is in the second position.According to variations, the dressing comprises an elastic material.According to variations, the dressing comprises a first attachmentregion coupled to the inner surface of the base structure and a secondattachment region coupled to the opposing surface of the coverstructure, wherein the cover and base are configured to exert astraining force to strain the dressing when the cover is moved from thefirst position to the second position. According to variations, atensioning structure is configured to exert the straining force on thedressing. According to variations, the tensioning structure comprises: afirst structure configured to couple the dressing at the firstattachment region to the inner surface of the base structure; and asecond structure configured to couple the dressing at the secondattachment region to the opposing surface of the cover; wherein thetensioning structure is configured to exert the straining force to thedressing between the first attachment region and the second attachmentregion when the cover structure is moved with respect to the basestructure from the first position to the second position. According tosome variations, the dressing has a first width when the cover is in thefirst position and a second width when the cover is in the secondposition, wherein the second width is greater than the first width.According to variations, the second width is at least 20% greater thanthe first width. According to variations, the second width is at least40% great than the first width. According to variations, the basestructure comprise at least one relatively rigid element and at leastone relatively flexible element, wherein the relatively rigid element issufficiently rigid to support the dressing when the straining force isapplied in a first direction; and wherein the relatively flexibleelement permits the base structure to flex in a second direction.According to variations, the at least one relatively rigid elementcomprises a plurality of flexible coupled, relatively rigid elements.According to variations, the cover structure comprises at least onerelatively rigid element and at least one relatively flexible element.According to variations, a release device is configured to release thedressing from the base structure after the dressing is applied to awound or skin of a subject. According to some variations, base structureis pivotably coupled to the cover structure.

According to variations, a dressing packaging assembly comprises: a basestructure having an inner surface and comprising at least one supportelement and at least one flexible element; and a dressing comprising afirst surface configured to be applied to a wound or skin of a subject,and a back surface, wherein at least a portion of the back surface isremovably coupled to the inner surface of the base structure. Accordingto variations, the at least one rigid element comprises a plurality ofrigid elements coupled to each other with the at least one flexibleelement. According to variations, a cover structure comprises anopposing surface configured to interface with the first surface of thedressing, wherein the cover structure is moveably coupled to the basestructure to move from a first position where the opposing surfaceinterfaces with the first surface of the dressing, to a second positionwhere the cover is separated from the first surface of the dressing.According to variations, the cover structure is pivotably coupled to thebase structure. According to variations, the cover structure comprisesat least one support element and at least one flexible elementsufficiently flexible to permit shaping of the cover structure.According to variations, the first surface of the dressing comprises anadhesive region. According to variations, the first surface of thedressing comprises an adhesive backing interfacing an adhesive region onthe dressing. According to variations, the opposing surface of the coverstructure comprises an adhesive backing covering the adhesive region inthe first position and separated from the adhesive region in the secondposition. According to variations, the dressing comprises and elasticmaterial. According to variations, the dressing comprises a firstattachment region coupled to the inner surface of the base structure anda second attachment region coupled to the opposing surface of the coverstructure, wherein the cover and base are configured to exert astraining force to strain the dressing when the cover is moved from thefirst position to the second position. According to variations, theassembly further comprises a tensioning structure configured to exertthe straining force on the dressing. According to variations, thetensioning structure comprises: a first structure configured to couplethe dressing at the first attachment region to the inner surface of thebase structure; and a second structure configured to couple the dressingat the second attachment region to the opposing surface of the cover;wherein the tensioning structure is configured to exert the strainingforce to the dressing between the first attachment region and the secondattachment region when the cover structure is moved with respect to thebase structure from the first position to the second position. Accordingto variations, the dressing between the first and second attachmentregions has a first width when the cover is in the first position and asecond width when the cover is in the second position, wherein thesecond width is greater than the first width. According to variations,the second width is at least 4% greater than the first width. Accordingto variations, the second width is at least 20% greater than the firstwidth. According to variations, the second width is at least 40% greatthan the first width.

According to variation, a method of applying a dressing to a wound orskin of a subject comprises: providing a dressing packaging assemblycomprising: a base structure having an inner surface; a cover structurehaving an opposing surface, wherein the base structure is movablycoupled to the cover structure; and a dressing comprising a firstsurface including an adhesive region, and a back surface, wherein atleast a portion of the back surface is removably coupled to the innersurface of the base structure, and wherein the opposing surface of thecover structure comprises an adhesive backing covering the adhesiveregion when the cover structure is in the first position; pivoting thecover structure with respect to the base structure to a second positionto separate the opposing surface from the first surface of the dressingand to separate the adhesive backing from the adhesive region; applyingthe first surface of the dressing to a wound or skin of a subject, thensubsequently releasing the dressing from the base structure. Accordingto variations of the method, at least a portion of the back surface ofthe dressing is coupled to the cover structure and further comprisingpivoting the cover structure with respect to the base structure tostrain the dressing.

According to variations, a dressing applicator comprises a firstdressing attachment region and a second dressing attachment regioncomprising a variable separation distance between the first dressingattachment region and the second dressing attachment region, and abending region between the first dressing attachment region and thesecond dressing attachment region that alters the variable separationdistance, and wherein a first distance from a center of the bendingregion to the first dressing attachment area is different from a seconddistance from the center of the bending region to the second dressingattachment area.

According to variations, a dressing tensioning device comprises: adressing carrier comprising a first carrier edge and a second opposingcarrier edge defining a carrier width therebetween; a tensioning elementconfigured to move with respect to the dressing carrier from a firstposition to a second dressing tensioning position; and a dressingassembly comprising a dressing including a first dressing edge coupledto the carrier adjacent the first carrier edge; a second dressing edgecoupled to an attachment element wherein the attachment element coupledto the tensioning element; wherein in the first position of thetensioning element, the second dressing edge is a first distance fromthe second carrier edge within the width of the carrier, and in thesecond position of the tensioning element, the second dressing edge is asecond distance from the second carrier edge within the width of thecarrier, wherein the first distance is greater than the second distance.According to variations, the first dressing edge is relatively fixedwith respect to the second dressing edge when the tensioning element ismoved between the first and second positions.

According to variations, a dressing packaging assembly comprises: a basestructure having an inner surface; a cover structure having an opposingsurface, wherein the base structure is movably coupled to the coverstructure; and a dressing comprising a first surface configured to beapplied to a wound or skin of a subject, and a back surface, wherein atleast a portion of the back surface is removably coupled to the innersurface of the base structure; wherein the cover structure is configuredto move from a first position where the opposing surface interfaces withthe first surface to the dressing to a second position where theopposing surface is separated from the first surface of the dressingwhere the second position is at least about 180 degrees rotated withrespect to the first position. According to variations, the firstsurface of the dressing comprises an adhesive region. According tovariations, the first surface of the dressing comprises an adhesivebacking interfacing an adhesive region on the dressing. According tovariations, the opposing surface of the cover structure comprises anadhesive backing covering the adhesive region when the cover structureis in the first position and separated from the adhesive region when thecover structure is in the second position. According to variations, thedressing comprises an elastic material. According to variations, thedressing comprises a first attachment region coupled to the innersurface of the base structure and a second attachment region coupled tothe opposing surface of the cover structure, wherein the cover and baseare configured to exert a straining force to strain the dressing whenthe cover is moved from the first position to the second position.According to variations, the assembly further comprises a tensioningstructure configured to exert the straining force on the dressing.According to variations, the tensioning structure comprises: a firststructure configured to couple the dressing at the first attachmentregion to the inner surface of the base structure; and a secondstructure configured to couple the dressing at the second attachmentregion to the opposing surface of the cover; wherein the tensioningstructure is configured to exert the straining force to the dressingbetween the first attachment region and the second attachment regionwhen the cover structure is moved with respect to the base structurefrom the first position to the second position. According to variations,the dressing has a first width when the cover is in the first positionand a second width when the cover is in the second position, wherein thesecond width is greater than the first width. According to variations,the second width is at least 20% greater than the first width. Accordingto variations, the second width is at least 40% great than the firstwidth. According to variations, the base structure comprises at leastone relatively rigid element and at least one relatively flexibleelement, wherein the relatively rigid element is sufficiently rigid tosupport the dressing when the straining force is applied in a firstdirection; and wherein the relatively flexible element permits the basestructure to flex in a second direction.

According to variations, a dressing packaging comprises: a dressingcarrier comprising a first carrier edge, a second carrier edge opposingthe first carrier edge, and a support structure extending between thefirst edge and the second edge, configured to support a dressing duringapplication of the dressing to a subject; and a dressing comprising afirst dressing edge, a second dressing edge opposing the first dressingedge, a back surface and an opposing skin interfacing surface, whereinat least a portion of the back surface is removably coupled to thedressing carrier wherein the first dressing edge and the second dressingedge are positioned between the first carrier edge and the secondcarrier edge, and wherein the first dressing edge defines a first marginbetween the first dressing edge and the first carrier edge and thesecond dressing edge defines a second margin between the second dressingedge and the second carrier edge, wherein each of the first and secondmargins have a width of at least three millimeters.

In one variation, a dressing system is provided, comprising a firstsupport, a second support, and a primary bending region therebetween,the primary bending region comprising a primary bending axis, and atreatment device comprising a first attachment region attached to thefirst support and a second attachment region attached to the secondsupport, a first separation region configured to separate from firstattachment region and a second separation region configured to separatefrom the second attachment region. The first and second separationregions may comprise perforations. The dressing system may furthercomprise a pull element located along the perforations. The treatmentdevice may be asymmetrically attached to the first and second supports,relative the primary bending region. A first distance between the firstsupport and the primary bending axis may be different from a seconddistance between the second support and the primary bending axis. Thedressing system may further comprise a closed configuration wherein thetreatment device is located between the first support and the secondsupport, and a closed configuration wherein the second support islocated between the first support and the treatment device. The secondsupport may comprise at least one secondary bend region comprising asecondary bending axis that is not parallel to the primary bending axis.The secondary bending axis may be orthogonal to the primary bendingaxis. The first support may comprise at least one secondary bend regioncomprising a secondary bending axis that is not parallel to the primarybending axis. The at least one secondary bend region of the firstsupport may be aligned with the at least one secondary bend region ofthe second support. The treatment device may further comprise a releaseliner coupled to an adhesive surface of the treatment device. Thetreatment device may comprise a perforation region. The dressing systemmay further comprise an elongate element attached adjacent to theperforation region. The elongate element may protrude beyond theperforation region of the treatment device. In some variations, at leasta portion of the elongate element may be folded, and the fold may bealong a substantial length of the treatment device. At least one of thefirst and second supports may comprise indicia identifying a centerregion of the treatment device. The indicia may comprise a recessededge, ink mark, embossing, or window. The primary bending region mayalso perforated. The first support may be configured to detach from thesecond support and the treatment device, and may or may not do so whilemaintaining the treatment device in a strained configuration. The secondsupport may comprise an adhesive element configured to adhere to thetreatment device when the dressing system is in the open configurationbut not in the closed configuration. The first support may comprise anattached release liner. The release liner may be attached to the firstsupport between an outer edge of the first support and the attachedtreatment device. An inner surface of the first and/or second supportfacing the treatment device may include an adhesive, such as an adhesivecoating or adhesive tape, which is configured to maintain the treatmentdevice either in a tensioned state as it is stretched and contacts theadhesive, and/or to maintain the treatment device against the firstand/or second supports.

In another variation, a dressing system is provided, comprising a firsttensioning member, a second tensioning member, and a primary bendingregion therebetween, the primary bending region comprising a primarybending axis, and a treatment device asymmetrically attached to thefirst and second tensioning members, relative the primary bendingregion. The treatment device may comprises a first end attached to thefirst tensioning member and a second end attached to a second tensioningmember, wherein a first distance between the first tensioning member andthe primary bending axis is different from a second distance between thesecond tensioning member and the primary bending axis. The dressingsystem may further comprise a closed configuration wherein the treatmentdevice is located between the first tensioning member and the secondtensioning member, and an open configuration wherein the secondtensioning member is located between the first tensioning member and thetreatment device. The second tensioning member may comprise at least onesecondary bend region comprising a secondary bending axis that is notparallel to the primary bending axis. The secondary bending axis may beorthogonal to the primary bending axis. The first tensioning member maycomprise at least one secondary bend region comprising a secondarybending axis that is not parallel to the primary bending axis. The atleast one secondary bend region of the first tensioning member may bealigned with the at least one secondary bend region of the secondtensioning member. The treatment device may further comprise a releaseliner coupled to an adhesive surface of the treatment device. Thetreatment device may comprise a perforation region. The dressing systemmay further comprise an elongate element attached adjacent to theperforation region. The elongate element may protrude beyond theperforation region of the treatment device. In some variations, at leasta portion of the elongate element may be folded, and the fold may bealong a substantial length of the treatment device. At least one of thefirst and second tensioning members may comprise indicia identifying acenter region of the treatment device. The indicia may comprise arecessed edge, ink mark, embossing, or window. The primary bendingregion may be perforated. The first tensioning member may be configuredto detach from the second tensioning member and the treatment device.The first tensioning member may be configured to detach from the secondtensioning member and the treatment device while maintaining thetreatment device in a strained configuration. The second tensioningmember may comprise an adhesive element configured to adhere to thetreatment device when the dressing system is in the open configurationbut not in the closed configuration. The first tensioning member maycomprise an attached release liner. The release liner may be attached tothe first tensioning member between an outer edge of the firsttensioning member and the attached treatment device.

In another variation, a dressing system is provided, comprising a firstapplicator member, a second applicator member, and a primary bendingregion therebetween, the primary bending region comprising a primarybending axis, and a treatment device attached to the first and secondapplicator members, wherein the dressing system comprises a closedconfiguration wherein the treatment device is located between the firstapplicator member and the second applicator member, and a closedconfiguration wherein the second applicator member is located betweenthe first applicator member and the treatment device. The secondapplicator member may comprise at least one secondary bend regioncomprising a secondary bending axis that is not parallel to the primarybending axis. The secondary bending axis may be orthogonal to theprimary bending axis. The first applicator member may comprise at leastone secondary bend region comprising a secondary bending axis that isnot parallel to the primary bending axis. The at least one secondarybend region of the first applicator member may be aligned with the atleast one secondary bend region of the second applicator member. Thetreatment device may further comprise a release liner coupled to anadhesive surface of the treatment device. The treatment device maycomprise a perforation region. The dressing system may further comprisean elongate element attached adjacent to the perforation region. Theelongate element may protrude beyond the perforation region of thetreatment device. At least a portion of the elongate element may befolded, and the fold may be along a substantial length of the treatmentdevice. At least one of the first and second applicator members maycomprise indicia identifying a center region of the treatment device.The indicia may comprise a recessed edge, ink mark, embossing, orwindow. The primary bending region may be perforated. The firstapplicator member is configured to detach from the second applicatormember and the treatment device. The first applicator member may beconfigured to detach from the second applicator member and the treatmentdevice while maintaining the treatment device in a strainedconfiguration. The second applicator member may comprise an adhesiveelement configured to adhere to the treatment device when the dressingsystem is in the open configuration but not in the closed configuration.The first applicator member may comprise an attached release liner. Therelease liner may be attached to the first applicator member between anouter edge of the first applicator member and the attached treatmentdevice.

Devices, kits and methods described herein are provided for treatment toskin, including but not limited to wound healing, the treatment,amelioration, and/or prevention of scars or keloids. A book-likepackaging, applicator and/or tensioning device is used to apply adressing to a subject. The packaging, applicator and/or tensioningdevice applies and/or maintain a strain in an elastic dressing, andinclude undulating edge configurations to reduce peak stresses appliedto the skin compared to traditional dressing shapes

In one embodiment, a tissue treatment device is provided, comprising anelastic sheet, the elastic sheet comprising a planar skin interfacingsurface, a first undulating edge, and a second undulating edge farthestand opposite from the first edge, wherein the elastic sheet may furthercomprise a first tensile stressed configuration and a second tensilestressed configuration, wherein the skin interfacing surface isconfigured to adhere to skin in the first tensile stressed configurationand configured to partially relax to the second tensile stressedconfiguration to compress the adhered skin, wherein the undulating edgesare configured to reduce localized tensile stresses at one or morelocations along the first undulating edge and the second undulatingedge, and wherein each undulating edge comprises at least twoconsecutive extensions with an average amplitude, and a minimumseparation of at least 2 mm and an average peak-to-peak distance that isequal to or less than twice the average amplitude. Each undulating edgemay further comprise at least one of curved edge segments or straightedge segments, and wherein the first edge and the second edge each lacksharp angles and sharp vertices. The average amplitude of the firstundulating edge may be at least 4 mm, and may be no more than 20 mm. Theratio of the average amplitude and the average peak-to-peak distance maybe in the range of about ⅓ to about 2, or may be in the range of about0.8 to about 1.2. The elastic sheet may further comprise a third edgespanning between first and second edge and a fourth edge spanningbetween the first edge and second edge farthest and opposite the thirdedge. The elastic sheet may further comprise rounded corners between thefirst and third edges, the first and fourth edges, the second and thirdedges and the second and fourth edges, and wherein the minimum radius ofcurvature of the rounded corners is at least 5 mm. The third edge maycomprise at least three extensions and wherein the average peak-to-peakdistance of the third edge is different from the average peak-to-peakdistance of the first edge or second edge. The at least two consecutiveextensions may each comprise a neck with a minimum extension widthlocated proximal to a distal end of the extension and a head locateddistal to the neck and with a maximum extension width that is largerthan the minimum extension width. Each head may comprise at least asemi-circular curved segment, or at least at least a three-quarterscircular curved segment. The minimum gap between each head may be atleast 2 mm, or at least 5 mm. The minimum gap between each neck is 5 mm.The maximum extension width may be between 5 mm and 8 mm. The minimumextension width may be in the range of about 1.5 mm to about 5.5 mm. Theaverage amplitude of the first undulating edge may be in the range ofabout 5 mm to about 10 mm.

In another embodiment, a tissue treatment device is provided, comprisingan elastic sheet with a planar skin interfacing surface, a first edgemeans for reducing peak stresses and a second edge means for reducingpeak stresses, wherein the second edge means is located farthest andopposite from the first edge means, a first tensile stressedconfiguration and a second tensile stressed configuration wherein theskin interfacing surface is configured to adhere to skin in the firsttensile stressed configuration and further configured to partially relaxto the second tensile stressed configuration and compress the adheredskin. The first edge means may comprise a first undulating edge with atleast two consecutive peaks, the at least two consecutive peakscomprising having an average amplitude and a peak-to-peak distance thatis at least 2 mm and is less than twice the average amplitude. Thesecond edge means may comprise a second undulating edge with at leasttwo consecutive peaks, the at least two consecutive peaks comprisinghaving an average amplitude and a peak-to-peak distance that is at least2 mm and is less than twice the average amplitude. The first edge meansmay comprise a first undulating edge with at least two consecutivepeaks, the at least two consecutive peaks comprising an averageamplitude and the tissue treatment device comprising a width and fromthe first undulating edge to the second undulating edge wherein averageamplitude is between about 10% and 40% of the width. The averageamplitude may be between about 12% and 35% of the width. The first edgemeans may comprise a first undulating edge with a plurality ofconsecutive extensions, each having a peak and an amplitude and aplurality of consecutive open areas each having a trough, defining amodulation zone, wherein the modulation zone has a total area defined bya proximal boundary along a line or curve of best fit along the troughs,an outer boundary along a line or curve of best fit along the peaks, afirst lateral boundary located at a first peak or a first troughimmediately adjacent to a peak, and a second lateral boundary located ata second peak or a second trough immediately adjacent to a peak that isdifferent from the first peak or first trough, wherein the plurality ofconsecutive open spaces have a total open space area, and wherein thetotal open space area is between about 25% and 80% of the total area ofthe modulation zone. The first lateral boundary and the second lateralboundary may be both peaks or both troughs. The first peak and thesecond peak are two peaks that are spaced farthest apart along the firstedge means. The first trough and the second trough may be two troughsthat are spaced farthest apart along the first edge means. The pluralityof consecutive extensions may comprise curved distal ends with radii ofcurvature that are at least 1 mm. The plurality of consecutive openareas may comprise curved trough bases with radii of curvature that areat least 1 mm.

In still another embodiment, a method of treating a patient is provided,comprising adhering an elastic sheet in a first stressed configurationto a treatment area, the elastic sheet comprising a planar skininterfacing surface, a first undulating edge, and a second undulatingedge farthest and opposite from the first edge, wherein the undulatingedges are configured to reduce localized tensile stresses at one or morelocations along the first undulating edge and the second undulatingedge, and wherein each undulating edge comprises at least twoconsecutive extensions with an average amplitude, and a minimumseparation of at least 2 mm and an average peak-to-peak distance that isequal to or less than twice the average amplitude, allowing the elasticsheet in the first stressed configuration to partially relax to a secondtensile stressed configuration to compress the adhered skin. The methodmay further comprise using an applicator to stretch the elastic sheetfrom an unbiased configuration to the first stressed configuration.

In another embodiment, a method of treating a patient is provided,comprising adhering an elastic sheet in a first stressed configurationto a treatment area, the elastic sheet comprising a planar skininterfacing surface, a first edge means for reducing peak stresses, anda second edge means for reducing peak stressed, located farthest andopposite from the first edge means, allowing the elastic sheet in thefirst stressed configuration to partially relax to a second tensilestressed configuration to compress the adhered skin. The method mayfurther comprise using an applicator to stretch the elastic sheet froman unbiased configuration to the first stressed configuration.

In one embodiment, a tissue treatment device is provided, comprising anelastic sheet, comprising a total surface area and a net edge length, aplanar skin interfacing surface, a first undulating edge, and a secondundulating edge farthest and opposite from the first edge, wherein theelastic sheet may further comprise a first tensile stressedconfiguration and a second tensile stressed configuration, wherein theskin interfacing surface is configured to adhere to skin in the firsttensile stressed configuration and configured to partially relax to thesecond tensile stressed configuration to compress the adhered skin,wherein the undulating edges are configured to reduce traction forcesimparted by the dressing at one or more locations along the firstundulating edge and the second undulating edge, relative to an elasticsheet with the same total surface area but a smaller edge length. Eachundulating edge may comprise at least two consecutive extensions with anaverage amplitude, and a minimum separation of at least 2 mm and anaverage peak-to-peak distance that is equal to or less than twice theaverage amplitude.

In another embodiment, a tissue treatment device is provided, comprisingan elastic sheet, the elastic sheet comprising a planar skin interfacingsurface, a first undulating edge, and a second undulating edge farthestand opposite from the first edge, wherein the elastic sheet furthercomprises a first tensile stressed configuration and a second tensilestressed configuration, wherein the skin interfacing surface isconfigured to adhere to skin in the first tensile stressed configurationand configured to partially relax to the second tensile stressedconfiguration to compress the adhered skin, wherein the undulating edgesare configured to reduce traction forces imparted by the dressing, at ornear one or more locations along the first undulating edge and thesecond undulating edge, and wherein the first undulating edge and secondundulating edge define a width dressing width and wherein eachundulating edge comprises at least two consecutive extensions with anaverage amplitude, wherein the average amplitude is between about 10%and 40% of the dressing width. The average amplitude may be betweenabout 12% and 35% of the dressing width. Each undulating edge furthercomprises at least one of curved edge segments or straight edgesegments, and wherein the first edge and the second edge each lack sharpangles and sharp vertices.

In another embodiment, a tissue treatment device is provided, comprisingan elastic sheet, the elastic sheet comprising a first undulating edgecomprising a plurality of consecutive extensions having an amplitudedefining a modulation zone, wherein the modulation zone has a total areadefined by defined by a proximal boundary along a line or curve of bestfit along the troughs, an outer boundary along a line or curve of bestfit along the peaks, a first lateral boundary located at a first troughimmediately adjacent to a peak, and a second lateral boundary located ata second trough immediately adjacent to a peak, wherein the first andsecond troughs are two troughs on the first undulating edge that are thefarthest apart, wherein each of the plurality of consecutive extensionshaving an open space there between defining a total open space area,wherein the total open space area is between about 25% and 80% of thetotal area of the modulation zone, a planar skin interfacing surface,wherein the elastic sheet further comprises a first tensile stressedconfiguration and a second tensile stressed configuration, wherein theskin interfacing surface is configured to adhere to skin in the firsttensile stressed configuration and configured to partially relax to thesecond tensile stressed configuration to compress the adhered skin,wherein the undulating edges are configured to reduce traction forcesimparted by the dressing, at or near one or more locations along thefirst undulating edge and the second undulating edge, relative to anelastic sheet with the same total surface area but a smaller edgelength. The total open space area may be between about 30% and 70% ofthe total area of the modulation zone. Each undulating edge may compriseat least two consecutive extensions with a minimum separation of atleast 2 mm. The at least two consecutive extensions may comprise anaverage peak-to-peak distance that is equal to or less than twice theaverage amplitude. The elastic sheet may comprise a second undulatingconfigured to reducing peak stresses, wherein the second undulating edgeis located farthest and opposite from the first undulating edge. Theplurality of consecutive extensions may comprises curved distal endswith radii of curvature that are at least 1 mm, and wherein theplurality of consecutive open areas comprises curved trough bases withradii of curvature that are at least 1 mm.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a variation of a dressing and packagingassembly in a closed configuration.

FIG. 2 is a perspective view of the dressing and packaging assembly ofFIG. 1 with a cover open at about a ninety degree position from theclosed position.

FIG. 3 is a bottom perspective view of the dressing and packagingassembly of FIG. 1 with a cover open at about a 360 degree configurationfrom the closed position.

FIG. 4 is a top perspective view of the dressing and packaging assemblyof FIG. 1 with a cover open at about a 360 degree configuration from theclosed position.

FIG. 5A is a schematic bottom view of the dressing and packagingassembly in the position illustrated in FIG. 3.

FIG. 5B is a cross section of FIG. 5A along the lines C-C.

FIG. 5C is a cross section of FIG. 5A along the lines D-D.

FIG. 6 illustrates a variation of a dressing and packaging assembly.

FIG. 7 is a perspective view of a dressing and packaging assembly with acover in an open position 90 degrees from a closed position.

FIG. 8A is a schematic end view of the dressing and packaging assemblyof FIG. 7 in a strained configuration with the cover open at about 360degrees from a closed configuration.

FIG. 8B is an expanded view of section A of FIG. 8A.

FIG. 8C is an expanded view of section B of FIG. 8A.

FIG. 9 is a top perspective view of the dressing and packaging assemblyof FIG. 7 after release.

FIG. 10 is a perspective view of another example of a dressing andpackaging assembly in a closed configuration

FIG. 11 is a perspective view of the dressing and packaging assembly ofFIG. 10 with a cover in approximately 90 degree configuration from theclosed configuration.

FIG. 12A is a top perspective view of the dressing and packagingassembly of FIG. 10 with a cover in approximately a 360 degreeconfiguration from the closed configuration.

FIG. 12B is a bottom perspective view of the dressing and packagingassembly of FIG. 10 with a cover in approximately a 360 degreeconfiguration from the closed configuration.

FIG. 13 is a top view of a packaging device in an open configuration.

FIG. 14 is an exploded perspective view of a packaging device in an openconfiguration.

FIG. 15A is a perspective view of a variation of dressing and packagingassembly in an unstrained configuration.

FIG. 15B is a bottom 15F perspective view of the dressing and packagingassembly of FIG. 15A in a strained configuration.

FIG. 15C is a bottom perspective view of the dressing and packagingassembly of FIG. 15A after removing the cover of the carrier, support orbase.

FIG. 15D is a top perspective view of the device of FIG. 15A afterremoving the cover of the carrier, support or base.

FIG. 15E is a top perspective view of the device of FIG. 15A afterremoving the carrier, support or base.

FIG. 15F is a perspective view of a strained dressing after it isseparated from the attachment sheets.

FIG. 15G is a perspective view of a dressing assembly with attachmentsheets.

FIG. 15H is a perspective view of the dressing assembly of FIG. 15G withan attachment sheet peeled back.

FIG. 15I is a perspective view of the dressing assembly of FIG. 15G withan attachment sheet removed.

FIG. 15J is a cross section of the dressing assembly with attachmentsheets of FIG. 15G.

FIG. 16A is a perspective view of a variation of a dressing assemblywith removable attachment sheets.

FIG. 16B is a perspective view of the dressing assembly of FIG. 16A witha peeled removable attachment sheet.

FIG. 16C is a perspective view of the dressing assembly of FIG. 16A witha removed attachment sheet.

FIG. 16D is a cross section of the dressing assembly with attachmentsheets of FIG. 16A

FIG. 17A is a perspective view of a variation of a dressing assemblywith removable attachment sheets.

FIG. 17B is a perspective view of the dressing assembly of FIG. 17A witha peeled removable attachment sheet.

FIG. 17C is a perspective view of the dressing assembly of FIG. 17A witha removed attachment sheet.

FIG. 17D is a cross section of the dressing assembly with attachmentsheets of FIG. 17A.

FIG. 18A is a perspective view of a variation of dressing and packagingassembly in an unstrained configuration.

FIG. 18B is a top perspective view of the device of FIG. 18A in astrained and folded configuration.

FIG. 18C is a perspective view of the bottom side the device in thestrained and folded configuration of FIG. 18B.

FIG. 18D is a top perspective view of the device of FIG. 18A in astrained and folded configuration while detaching an attachment sheet.

FIG. 18E is a top perspective view of the device of FIG. 18A with afirst side of the dressing assembly detached from the carrier and thecover removed.

FIG. 18F is a top perspective of the device of FIG. 18A with thedressing assembly detached from the carrier.

FIG. 18G is a top perspective view of the device of FIG. 18A with thecarrier detached and removed.

FIG. 18H is a perspective view of the device of FIG. 18A with thedressing being separated from the attachment sheets.

FIG. 18I is a perspective view of the device of FIG. 18A with thedressing separated from the attachment sheets.

FIG. 18J is a side elevational view of the device in FIG. 18I.

FIG. 19A is a perspective view of a variation of a dressing and packingassembly device.

FIG. 19B is a top view of an unstrained configuration of a dressingassembly of FIG. 19A

FIG. 19C is a top view of a strained and attached configuration of thedressing assembly of FIG. 19B.

FIG. 19D is a top view of a strained and detached configuration of thedressing assembly of FIG. 19B.

FIG. 19E is a top view of a dressing of FIG. 19B.

FIG. 20A is a top view of a variation of a dressing carrier, support,base tensioning device or applicator.

FIG. 20B is a side view of the dressing carrier, support, basetensioning device or applicator of FIG. 20A in a first configuration.

FIG. 20C is a side view of the dressing carrier, support, basetensioning device or applicator of FIG. 20A in a second configuration.

FIG. 21A is a perspective view of a variation of a dressing carrier,support, base tensioning device or applicator

FIG. 21B is a top view of the dressing carrier, support, base tensioningdevice or applicator of FIG. 21A.

FIG. 21C is a side view of dressing carrier, support, base tensioningdevice or applicator of FIG. 21A.

FIG. 21D is a top view of the dressing carrier, support, base tensioningdevice or applicator of FIG. 21A in a flexed configuration.

FIG. 21E is a cross-section of FIG. 21D along the lines A-A

FIG. 22A is a perspective view of a variation of a dressing andpackaging assembly in an unstrained configuration.

FIG. 22B is a perspective view of a variation of a dressing andpackaging device in a strained configuration.

FIG. 23A is a schematic superior view of an alternate embodiment of adressing which may be used with the packaging devices herein; FIG. 23Bis a detailed view of an edge region of the dressing in FIG. 23A.

FIGS. 24A to 24F depict various alternate embodiments of dressing edgeregions.

FIG. 25 depicts a schematic cross section of a dressing applied to thestratum corneum of the skin.

FIG. 26A depicts a top view of a portion of a hypothetical straineddressing with a straight outer edge adhered to a layer of skin startingfrom its outer edge along a portion of a width of its width.

FIG. 26B depicts a schematic graph of hypothetical average shear stressexerted by a dressing to a layer of skin along a portion of treatmentzone starting from the outer edge of the dressing across the width ofskin shown in FIG. 26A.

FIG. 27A depicts a top view of a portion of a hypothetical straineddressing with a modulation edge zone having geometrical features,adhered to a layer of skin starting from its outermost edge along aportion of a width of its width.

FIG. 27B depicts a schematic graph of hypothetical average shear stressexerted by a dressing to a layer of skin along a portion of treatmentzone starting from the outer edge of the dressing across the width ofskin shown in FIG. 27A.

DETAILED DESCRIPTION

Previous attempts to treat scars and keloids have included surgery,silicone dressings, steroids, x-ray irradiation, and cryotherapy. Eachof these techniques has disadvantages. Perhaps the biggest disadvantageis that none of them effectively prevent or ameliorate the formation ofscars or keloids in the first instance. That is, these techniques haveprimarily been used to treat scars after they are already wellestablished.

Unloading of exogenous and/or endogenous stress in the vicinity of thewound may ameliorate the formation of scars, hypertrophic scars, orkeloids. The mechanical environment of an injury may be an importantfactor in tissue response to that injury. The mechanical environmentincludes exogenous stress (i.e., physiological stress which includesstress transferred to the wound via muscle action or physical bodymovement) and endogenous stress (i.e., dermal stress originating fromthe physical properties of the skin itself, including stress induced atthe wound site due to swelling or contraction of the skin). The devices,dressings, kits and methods described herein may control or regulate themechanical environment of a skin including but not limited to themechanical environment of a wound. The devices, dressings, kits andmethods described herein may also control or regulate the mechanicalenvironment to ameliorate scar and/or keloid formation. The mechanicalenvironment of skin may include stress, strain, or any combination ofstress and strain. The control of a wound's mechanical environment maybe active or passive, dynamic (e.g., by applying an oscillating stress)or static. The stresses and strains acting on the wound may involve thelayers of the skin, such as the outer stratum corneum, the epidermis anddermis, as well as the underlying connective tissue layers, such as thesubcutaneous fat. Devices and methods described here may shield a woundfrom its mechanical environment. The term “shield” is meant to encompassthe unloading of stress experienced by the wound as well as providing aphysical barrier against contact, contaminants, and the like. Thedevices and methods described here may shield a wound by unloading thewound and surrounding tissues from endogenous stress and/or exogenousstress. Thus, devices and methods described here may reduce the stressexperienced by a wound and surrounding tissues to a lower level thanthat experienced by normal skin and tissue. Unloading of exogenousand/or endogenous stress in the vicinity of the wound may ameliorate theformation of scars, hypertrophic scars, or keloids.

A cell's external mechanical environment may trigger biologicalresponses inside the cells and change cell behavior. Cells can sense andrespond to changes in their mechanical environment using integrin, anintegral membrane protein in the plasma membrane of cells, andintracellular pathways. The intracellular pathways are initiated byreceptors attached to cell membranes and the cell membrane that cansense mechanical forces. For example, mechanical forces can inducesecretion of cytokines, chemokines, growth factors, and otherbiologically active compounds that can increase or trigger theinflammatory response. Such secretions can act in the cells that secretethem (intracrine), on the cells that secrete them (autocrine), on cellssurrounding the cells that secrete them (paracrine), or act at adistance from the point of secretion (endocrine). Intracrineinterference can alter cell signaling, which can in turn alter cellbehavior and biology including the recruitment of cells to the wound,proliferation of cells at the wound, and cell death in the wound. Inaddition, the extracellular matrix may be affected.

As noted above, the wound healing process may be characterized in threestages: early inflammatory phase, the proliferative phase, andremodeling. The inflammatory phase occurs immediately after injury andtypically lasts about two days to one week. Blood clotting takes placeto halt blood loss and factors are released to attract cells that canremove debris, bacteria and damaged tissue from the wound. In addition,factors are released to initiate the proliferative phase of woundhealing. In the proliferative phase, which lasts about four days toseveral weeks, fibroblasts grow and build a new extracellular matrix bysecreting collagen and proteoglycans. At the end of the proliferativephase, fibroblasts can act to contract the wound further. In theremodeling phase, randomly oriented collagen is organized andcrosslinked along skin tension lines. Cells that are no longer neededcan undergo apoptosis. The remodeling phase may continue for many weeksor months, or indefinitely after injury. Scars typically reach about75-80% of normal skin breaking strength about 6-8 weeks after injury. Ingeneral, scars typically have a triangular cross-section. That is, ascar is usually smallest in volume near the skin surface (i.e., stratumcorneum and epidermis) and increases in volume as it progresses into thedeeper layers of the dermis.

There are three common possible outcomes to a wound healing process.First, a normal scar can result. Second, a pathologic increase in scarformation can result, such as formation of a hypertrophic scar or akeloid. Third, the wound may not heal completely and become a chronicwound or ulcer. The devices, kits and methods described herein canameliorate the formation of any type of scar. In addition, the devices,kits and methods described here can be adapted for a variety of woundsizes, and for different thicknesses of skin, e.g., the devices may beconfigured for use in different areas of the body. In addition, thedevices, kits and methods described here can be adapted to amelioratescar formation in any type of skin, e.g., body location, age, race, orcondition.

Without wishing to be bound by any particular theory, we believe thatmechanical strain acting on a wound or incision early in theproliferative phase of the wound healing process may inhibit cellularapoptosis, leading to a significant accumulation of cells and matrix,and hence increased scarring or the production of hypertrophic scars.Given the underlying similarities between hypertrophic scars and keloidswith respect to excessive matrix formation, we believe that the devicesand methods described herein may also be useful in preventing andtreating keloids by offloading or neutralizing at least some of thestrain that may be acting on the wound or incision. This tensile strainmay be exogenous and/or endogenous strain, and may include but is notlimited to the strain from the intrinsic tensile forces found in normalintact skin tissue.

A number of wound dressings have backings, adhesive liners and/orpackaging that are removed prior to application of a wound dressing.Many existing dressings can be clumsy to orient and apply and can have atendency to fold and adhere to themselves.

Devices, kits and methods described herein may treat skin at a skin site(“skin treatment device”), including without limitation, to amelioratethe formation of scars at wound sites by controllably stressing orstraining the epidermis and deeper layers of dermal tissue at or near askin site, i.e., at or adjacent a wound or treatment site of a subject'sskin, thereby reducing tensile or compressive stress at the skin site.The stress at the skin site may be reduced to levels below thatexperienced by normal skin and tissue. The stress or strain may beapplied to surrounding tissue in one, two, or more directions to reduceendogenous or exogenous stress at the skin site in one, two or moredirections. Thus, devices and methods described herein may reduce thestress experienced by skin and/or a wound and surrounding tissues inorder to treat a subject. The device may also assist in preventing orreducing the incidence of wound dehiscence.

Devices, kits and methods described herein may provide a packagingand/or applicator for a dressing. According to one variation, thepackaging and/or applicator is configured to provide quick or easypreparation and/or application of a dressing. While some examples hereinspecifically refer to a packaging that also acts as a tensioning deviceto pre-strain a dressing, other dressings that are not pre-strainedand/or strained prior to application may be provided in accordance withone or more variations or embodiments. The packaging may also operate asan applicator where one or more elements of the packaging may be used toposition and/or apply the dressing to the skin of a subject.

Devices kits and methods described herein may be for the preparationand/or application of a dressing. Such preparation may include but isnot limited to, for example, removal of an adhesive liner, straining ortensioning a dressing, orienting a dressing for application and/orapplying a medicament or other material to a portion of the dressingprior to application.

Backings, adhesive liners or release layers, and/or other packaging mayprovide some structural stability to a flexible wound dressing. However,when removed, the flexible wound dressing can be somewhat clumsy to usebecause it may fold and adhere to itself or the user, or otherwiseprovide for difficult positioning over the wound. Also the act ofpulling or removing the liner and reorienting the dressing to thepatient may increase the tendency to fold or flop. Furthermore, becauseof the folding or floppiness of the dressing, during adhesive removaland subsequent reorientation, the user has a significant possibility ofcompromising the sterility of a portion of the device to be applied to awound site.

According to another variation, a packaging or applicator is configuredto provide support for the dressing after the dressing is prepared andwhile the dressing is applied to a subject. According to somevariations, a backing provides structural support or stability of thedressing as and/or after an adhesive liner is released. According tosome variations, a dressing and packaging is configured to bepre-oriented in a position facing a wound i.e., for immediateapplication when and after the wound device is prepared for application.According to some variations, the packaging applicator is configured tobe used with one hand to orient and/or apply the device to the skin of asubject.

According to some variations, the packaging dressing carrier, support,base tensioning device or applicator tensioning device and/or applicatorprovide a release mechanism to separate the applied dressing from thepackaging and/or applicator after the dressing is applied to the skin.According to a variation, a dressing may be prestrained and coupled to adressing carrier, support, base tensioning device or applicator, forexample as set forth in U.S. Provisional Application Ser. No. 61/512,340filed on Jul. 17, 2011 and incorporated in its entirety herein byreference. One or more dressing releases described herein may be usedwith a dressing carrier, support, base tensioning device or applicator.

In some further variations, the dressing or one or more adhesive regionsof the dressing may be released, i.e., separated, from the liner byopening a packaging or applicator. According to some variations, abook-like packaging is provided with a cover, and a base to which adressing is removably attached. When or as the cover is opened, theliner may be manually or automatically released from the adhesive of thedressing. According to variations, a liner is attached to the cover andwill expose an adhesive side of a dressing when the cover is lifted oropened. The base may be configured to provide structural support to thedressing while the liner is removed and/or while the dressing is appliedto the skin of a subject.

According to some variations, the packaging, tensioning device, dressingcarrier, support, base or applicator may further comprise an opening, awindow, or a clear or semi-opaque portion through which a wound,incision or other location may be visualized as the dressing is appliedto the skin. According to some variations, the window guides theapplication of a dressing so that there is an optimal or desireddistance between the wound and the edges of the dressing and/or so thatthe dressing is in an optimal location for unloading skin stresses.

According to some variations the applicator, tensioning device,packaging or carrier, support, or base may provide varied or variableflexibility to allow the dressing to be shaped when applied to variousbody locations or contours.

According to some variations, a packaging or applicator is more rigid orprovides sufficient column strength in at least a first direction to besupportive of a dressing, while being relatively more flexible and lessrigid in at least second direction to provide for a more conformingapplication to a curved or shaped skin surface of a subject or to permitcurvature or shaping of the dressing where it is applied. The first andsecond directions may or may not be orthogonal to each other. Accordingto some variations, a packaging applicator, tensioning device ordressing carrier, support or base is sufficiently rigid or supportive ofa dressing while permitting shaping of the dressing, According to somevariations, the carrier or support which may include a base and/or acover may comprise segments of relatively more rigid material flexiblycoupled to adjacent segments to provide flexibility to permit shaping ofpackaging/applicator and/or dressing while providing sufficient supportof the dressing during application. According to some variations,segments are coupled to adjacent segments by way of a flexible material,such as a low-density polyethylene (LDPE) material, or a composite ofadhesive and a thinner more flexible substrate. Alternatively, segmentsmay be formed as a structure by manufacturing a substrate with cut-outs,slots, grooves, scoring or other openings or variations in thickness ofthe substrate at different locations.

The packaging, applicator, tensioning device, or dressing carrier mayhave elements or features the provide flexibility in one directionorthogonal to the plane of the support while limiting flexibility inanother direction orthogonal to the plane of the support. According tosome variations, the flexible elements may limit flexibility when thedevice is being strained and permit flexibility when the device is beingapplied to the skin. Each of the elements may permit flexing in adifferent direction than one or more of the other elements. Flexibleelements may be straight, or shaped according to a desired applicationor location of placement.

According to variations, flexible elements are provided in combinationwith support elements that provide sufficient support to allow a user tomaintain the dressing in a strained configuration. According tovariations, one or more elements may be provided to maintain a straineddressing in a strained configuration, for example a securing elementthat secures the dressing in a strained configuration until it isapplied to a subject and is released from the carrier, support, basetensioning device or applicator. For example, after straining thedressing, the dressing may be adhered or attached to one or moreelements of a dressing, support, base tensioning device or applicator ordressing assembly until it is released from the carrier, support, basetensioning device or applicator or assembly.

According to some variations, the applicator may be further used to helpreduce bleeding, e.g., by allowing application of a compressive forceusing a support structure while or after the device is applied. One ormore hemostatic or coagulative agents may be applied to, or otherwiseintegrated with dressing to help reduce bleeding. Potential agentsinclude chitosan, calcium-loaded zeolite, microfibrillar collagen,cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum,titanium oxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetylglucosamine, thrombin, coagulation factor(s) (e.g. II, VII, VII, X,XIII, Von Willebrand factor), procoagulants (e.g. propyl gallate),antifibrinolytics (e.g. epsilon aminocaproic acid), and the like. Insome variations, the agents may be freeze-dried and integrated into thedressing and activated upon contact with blood or other fluid. In somefurther variations, an activating agent may be applied to the dressingor the treatment site before the dressing is used on the subject. Instill other examples, the hemostatic agent may be applied separately anddirectly to the wound before application of the dressing, or afterapplication to the dressing via a catheter or tube. The devices may alsocomprise one or more other active agents that may be useful in aiding insome aspect of the wound healing process. For example, the active agentmay be a pharmaceutical compound, a protein (e.g., a growth factor), avitamin (e.g., vitamin E), or combinations thereof. A further example ofsuch medicament may include, but is not limited to various antibiotics(including but not limited to cephalosporins, bactitracin, polyxyxin Bsulfate, neomycin, polysporin), antiseptics (such as iodine solutions,silver sulfadiazine, chlorhexidine), antifungals (such as nystatin),antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus,paclitaxel), grow factors (such as VEGF) and other treatments (e.g.botulism toxin. Of course, the devices may comprise more than onemedicament or agent, and the devices may deliver one or more medicamentsor agents.

According to one variation, the applicator and or packaging may besufficiently supportive or rigid to hold a dressing's form so that it iseasy to manipulate. According to a variation, the applicator may besufficiently wider and/or longer or have a sufficiently larger area thana dressing so that it may provide sterile application and/or one-handedapplication. According to variations, a support structure is providedfor a dressing. According to a variation, a margin is provided as asupport structure between the dressing or dressing adhesive and one ormore edge portions of the support structure. Such margins provide asupported edge or area to grasp or manipulate the dressing or itscarrier, base or support, without necessitating or creating a greaterlikelihood of inadvertent user contact with the adhesive.

According to some variations, the packaging or applicator may also beused to strain a dressing prior to application to provide a dressingconfigured to ameliorate scar or keloid formation.

Devices are described here that may be used for ameliorating theformation of scars and/or keloids at a skin or wound site. The scars maybe any type of scar, e.g., a normal scar, a hypertrophic scar, etc. Ingeneral, the devices may be configured to be removably secured to a skinsurface near a wound. The devices may shield the skin or wound fromendogenous stress and/or exogenous stress. In some variations, thedevices may shield the skin or wound from endogenous stress withoutaffecting exogenous stress on the skin or wound, e.g., devices thatmodify the elastic properties of the skin, etc. In other variations, thedevices may shield the skin or wound from exogenous stress withoutaffecting endogenous stress on the wound. Such variations may includesituations where the musculature and surrounding skin or wound tissuehas been paralyzed, e.g., through the use of botulinum toxin or thelike. In still other variations, the devices shield the skin or woundfrom both endogenous and exogenous stress.

The devices or dressings described herein may treat skin at a skin siteincluding without limitation to ameliorate the formation of scars atwound sites by controllably stressing or straining the epidermis anddeeper layers of dermal tissue at or near a skin site, thereby reducingtensile or compressive stress at the skin site itself. The stress at theskin site may be reduced to levels below that experienced by normal skinand tissue. The stress or strain may be applied to surrounding tissue inone, two, or three directions to reduce endogenous or exogenous stressat the skin site in one, two or three directions. The physicalcharacteristics of the dressing and/or the method of applying thedressing may also be further configured to resist or reduce the rate ofskin stripping or tension blistering from the application of strain tothe incision site. For example, the stretching of the adhesive regionswhen applied to the skin surface may result in an increased tissuedensity under the adhesive region. This may be the result of generallyplanar, tangential or parallel compression of skin tissue that isdirectly attached to that adhesive region, resulting from the relaxationof the adhesive region. In some examples, this tissue compression mayreduce the risk of tissue stripping and/or blistering of skin in directcontact with the adhesive, in contrast to bandage “strapping” where oneend of a bandage is adhered to the skin and then tensioned or pulledacross a wound before the other end is attached to the skin on theopposite side of the wound. Bandage “strapping”, while generatingtension in the bandage during the application, may simultaneouslygenerate a relatively high tissue strain at the first adhesion site.This high tissue strain then decreases when the bandage is attached tothe skin at a second adhesion site as the high peak stresses areredistributed along the skin under the bandage. In contrast, when apre-strained bandage is applied to the skin, little if any strain may betransferred or generated in the skin as the adhesive regions are appliedto the desired locations. When the pre-strained bandage is permitted torelax, however, the strain (or peak strain) in the skin may beincreased. Thus, with a pre-strained bandage, temporary high tissuestrain may be avoided or otherwise reduced during the applicationprocedure. In other variations, however, the dressing may also beapplied to the skin by strapping, or by a combination of pre-strainingand strapping.

The dressing may comprise an elastic member, such as a sheet of elasticmaterial. The elastic material of the dressing may comprise a singlelayer of material or multiple layers of the same or different materials.The material may have any of a variety of configurations, including asolid, foam, lattice, or woven configuration. The elastic material maybe a biocompatible polymer, e.g., silicone, polyurethane, TPE(thermoplastic elastomers), synthetic rubber or co-polyester material.The thickness of polymer sheets may be selected to provide the dressingswith sufficient load carrying capacity to achieve desired recoverablestrains, and to prevent undesired amounts of creep deformation of thedressings over time. In some variations, the thickness across dressingsis not uniform, e.g., the thickness across the dressing may be varied tochange the stiffness, the load carrying capacity, or recovery strains inselected orientations and/or locations. The elastic material of theexemplary dressing may have a thickness in the range of about 50 micronsto 1 mm or more, about 100 microns to about 500 microns, about 120microns to about 300 microns, or in some variations about 200 microns toabout 260 microns. The exemplary dressings have an edge thickness ofabout 500 microns or less, 400 microns or less, or about 300 microns orless may exhibit less risk of skin separation from inadvertent liftingwhen inadvertently brushed against clothing or objects. In somevariations, the dressings are tapered near the edges to reducethickness. A tapered edge may also ameliorate peak tensile forces actingon skin tissue adjacent to the adhesive edges of the dressing. This mayor may not reduce the risk of skin blistering or other tension-relatedskin trauma. In other variations, the edges of the dressing may bethicker than the middle of the dressing. It is hypothesized that in someconfigurations, a thicker dressing edge may provide a relative inwardshift of the location of the peak tensile forces acting near thedressing edge, compared to dressings of uniform thickness. The elasticmaterial may have a load per width of at least 0.35 Newtons per mm at anengineering strain of 60% or a load per width of at least 0.25 Newtonsper mm at an engineering strain of 45%. The elastic material may have aload per width of no greater than about 2 Newtons per mm at theengineering strain of about 45% to 60%, about 1 Newtons per mm at theengineering strain of about 45% to 60%, about 0.7 Newtons per mm at theengineering strain of about 45% to 60%, or no greater than about 0.5Newtons per mm at the engineering strain of about 45% to 60%. The systemelastic material may have a load per width that does not decrease froman engineering strain of 0% to 60%, a load per width plot that increaseslinearly from an engineering strain of 0% to 60%, or a load per widthplot that is not convex from an engineering strain of 0% to 60%. Theelastic material may comprise an adhesive configured to maintain asubstantially constant stress in the range of 200 kPa to about 500 kPafor at least 8 hours when strained to an engineering strain of about 20%to 30% and attached to a surface. The elastic material may comprise anadhesive configured to maintain a substantially constant stress in therange of 200 kPa to about 400 kPa for at least 8 hours when strained toan engineering strain of about 20% to 30% and attached to a surface. Thesubstantially constant stress may vary by less than 10% over at least 8hours, or by less than 5% over at least 8 hours.

Although the depicted dressings may have a generally rectangularconfiguration with a length and/or width of about 160 mm to about 60 mm,in other variations the dressing may have any of a variety of lengthsand widths, and may comprise any of a variety of other shapes. Also, thecorners of the dressing may be squared or rounded, for example. Thelengths and/or widths of an exemplary dressing may be in the range ofabout 5 mm to about 1 meter or more, in some variations about 20 mm toabout 500 mm, and in other variations about 30 mm to about 50 mm, and instill other variations about 50 mm to about 100 mm. In some variations,the ratio of the maximum dimension of the dressing (e.g. its length) toan orthogonal dimension to the maximum dimension (e.g. width), excludingthe minimum dimension of the dressing (e.g. the thickness), may be inthe range of about 1:3, about 1:2, about 1:1, about 2:1, about 3:1,about 4:1 about 5:1, about 6:1, about 7:1, about 8:1, about 9:1 or about10:1 or greater. In some variations, the strain axis of the dressing inuse may be oriented with respect to the maximum dimension or to theorthogonal dimension to the maximum dimension. In some variations, thefinal compressive stress and strain imposed onto the skin by the elasticmaterial may be the result of the dynamic equilibrium between thetensile stress in the skin and the elastic material of the dressing. Theskin at the skin site typically comprises an inherent tension thatstretches incision site, whether or not any tissue was excised from theskin site. The elastic material and the adhesive region may beconfigured to be applied to a skin location so that when the dressing isstretched to a particular tension and then adhered to the incision site,tensile stress in the dressing is transferred to the incision site tocompress the tissue directly under the dressing along a tangential axisto the skin surface, the stress and strain imposed onto the skinlocation has a net or resultant orientation or axis is also generallytangential or planar to the elastic material and/or the outer surface ofthe skin location, with a similar axis to the orientation or axis of thetensile stress in the dressing. The tension in the dressing will relaxto a tension level that maintains equilibrium with increased tension inthe skin adjacent to the dressing. The application of the dressing tothe skin location may involve the placement of the dressing withoutoverlapping or being wrapped onto itself, e.g. wherein only adjacentregions of the dressing are interconnected and wherein non-adjacentregions of the dressing are not interconnected. The actual amount ofstress and strain imposed on the skin may vary, depending upon theparticular person, skin location, the thickness or various mechanicalcharacteristics of the skin layers (e.g. epidermis, dermis, orunderlying connective tissues), and/or the degree of pre-existingscarring, for example. In some further variations, the wound treatmentdressing may be selected or configured for use at a specific bodylocation, such as the scalp, forehead, cheek, neck, upper back, lowerback, abdominal region, upper torso (including but not limited to thebreast folds), shoulder, upper arm, lower arm, palm regions, the dorsumof the hand, finger, thigh, lower leg, the dorsum or plantar surface ofthe foot, and/or toe. Where applicable, some body regions may be furtherdelineated into anterior, posterior, medial, lateral, proximal and/ordistal regions, e.g. the arms and legs.

The dressing may be configured to impose a skin strain in the range ofabout 10% to about 60% or more, in other configurations about 15% toabout 50%, and in still other configurations, about 20% to about 30% orabout 40%. To achieve the desired degree of skin strain, the dressingmay be configured to undergo elastic tensile strain in the range ofabout 20% to about 80% or more, sometimes about 30% to about 60%, andother times about 40% to about 50% or about 60%. The dressing maycomprise any of a variety of elastic materials, including but notlimited to silicones, styrenic block copolymers, natural rubbers,fluoroelastomers, perfluoroelastomers, polyether block amides,thermoplastic elastomers, thermoplastic polyurethane, polyisoprene,polybutadiene, and the like. The material of the exemplary dressing mayhave a Shore A durometer in the range of about 20 to about 90, about 30to about 80, about 50 to about 80. The exemplary dressing wasconstructed of MED 82-5010-05 by NUSIL TECHNOLOGY LLC (Carpinteria,Calif.). Other examples of suitable materials are described in U.S.application Ser. No. 11/888,978, which was previously incorporated byreference in its entirety.

When the dressing is applied to a skin location and allowed to at leastpartially recover to its base configuration, the recovery level orequilibrium level of strain in the dressing may be in the range of about4% to about 60% or more, in other configurations about 15% to about 50%,and in still other configurations, about 20% to about 30% or about 40%.The ratio between the initial engineering tensile strain placed onto thedressing before recovery and the resulting engineering compressivestrain in the skin may vary depending upon the skin type and location,but in some examples, may be about 2:1. In other examples, the ratio maybe in the range of about 4:1 to about 5:4, about 3:1 to about 5:3, orabout 5:2 to about 2:1. These skin strain characteristics may bedetermined with respect to a reference position of the body or bodypart, e.g. anatomical position, to facilitate reproducible measurements.The particular degree of strain may be characterized as either anengineering strain or a true strain, but may or may not be calculatedbased upon or converted from the other type of strain (e.g. the strainmay be based upon a 45% engineering strain that is converted to a truestrain).

In some further variations, one or more characteristics of the elasticmaterial may correspond to various features on the stress/strain curveof the material. For example, the engineering and true stress/straincurves for one specific example of the dressing comprises a materialthat exhibits an engineering stress of about 1.2 MPa at about 60%engineering strain, but in other examples, the engineering stress may bein the range of about 900 KPa to about 3.5 MPa, about 1 MPa to about 2.2MPa, about 1 MPa to about 2 MPa, about 1.1 MPa to about 1.8 MPa, about1.1 MPa to about 1.5 MPa, about 1.2 MPa to about 1.4 MPa. When unloadingor relieving stress from the dressing, the material may be configuredwith an engineering stress of about 380 KPa at about 40% engineeringstrain, but in other examples, the engineering stress during unloadingof the material to about a 40% strain may be in the range of about 300KPa to about 700 KPa, about 325 KPa to about 600 KPa, about 350 KPa toabout 500 KPa, or about 375 KPA to about 425 KPa. When unloading thematerial to an engineering strain of about 30%, the material exhibits anengineering stress of about 300 KPa, but in other examples, theengineering stress when unloading the material to about 30% strain maybe in the range of about 250 KPa to about 500 KPa, about 275 KPa toabout 450 KPa, about 300 KPa to about 400 KPa, or about 325 KPA to about375 KPa. When unloading to an engineering strain of about 20%, thematerial may have an engineering stress of about 100 KPa, but in otherexamples, the unloading engineering stress at about 20% may be in therange of about 50 KPa to about 200 KPa, about 75 KPa to about 150 KPa,or about 100 KPa to about 125 KPa. In some examples, the material may beconfigured to at least achieve a specific range or level of engineeringstress at each of the specified engineering strain levels describedabove, but in other examples, the material may be configured for lowerlevels of maximum engineering strain, e.g. up to about 30% or about 40%.

In some examples, certain portions of the stress/strain curve may have aparticular morphology. For example, for a particular level of maximumstrain the loading curve may be generally linear on the correspondingtrue stress/strain curve. In an example using a dressing describedherein, up to a true strain of about 45%, the loading curve had agenerally linear configuration. In other examples, the configuration mayonly be linear along a portion of the loading curve or may be curvedalong the entire loading curve. Where the loading curve is non-linear,the loading curve may be convex, concave or both. Also, in someexamples, the tangent line of the loading curve (i.e. the line betweenthe two triangles) may also be generally co-linear.

In some variations, the elastic material comprises a material having anelastic modulus E of at least about 1 MPa, about 1.5 MPa, about 2 MPa,about 2.5 MPa, about 3 MPa, about 3.5 MPa, about 4 MPa, about 5 MPa,about 6 MPa, about 7 MPa, about 8 MPa, about 9 MPa or at least about 10MPa or greater. The material elastic modulus E may be no greater thanabout 10 MPa, about 9 MPa, about 8 MPA, about 7 MPa, about 6 MPa, orabout 5 MPa, or about 4 MPa.

In addition to the absolute stress levels at certain strain levelsdescribed above, the material may also be characterized with respect tothe ratio between a) the stress to achieve a particular strain duringloading, and b) the stress at the same strain during unloading. Forexample, the material may have a ratio of at least 4:1 to about 3:2 ateach of the 20%, 30% and 40% strain levels, but in other examples, thematerial may exhibit these ratios only at 20%, at 30%, or at 40% strainlevels, or at both 20% and 30% but not 40%, or at both 30% and 40% butnot 20%. In other examples, the ratio at one, some or all of the strainlevels may be in the range of about 3:1 to about 2:1, or about 5:2 toabout 2:1.

In some examples, the elastic material of the dressing may be configuredunder testing conditions to achieve a stable level of stress at aconstant strain, e.g. the material exhibits a limited amount of stressrelaxation over a particular period of time and at a particular level ofstrain. The period of time may be at least about 8 hours, about 12hours, about 18 hours, about 24 hours, about 36 hours, about 48 hours,about 72 hours, about 4 days, about 5 days, about 6 days, or about aweek or more. The level of strain may be about 10%, about 20%, about30%, about 40%, about 50%, about 60%, about 70%, or about 80% or more.The stress of the exemplary dressing over various time curves may beconfigured to maintain an engineering stress of about 300 KPa at anengineering strain of about 30% without noticeable deviation over aperiod of about 1 hour, about 2 hours, about 3 hours, about 4 hours,about 5 hours, about 6 hours, about 7 hours, or about 8 hours or more.The stresses at 10% strain, 20% strain, and at 40% may be lower orhigher.

In some variations, the elastic material or the dressing may beconfigured under testing conditions to maintain a particular minimumlevel of stress when held at a constant strain over a particular timeperiod. In an example to assess the ability of a backing material tomaintain a stress and strain on skin over time, engineering strains weremeasured while each backing material was tensile strained to 60% at arate of 100 microns per second and held for 10 minutes, and then droppedto a strain of 30% at a rate of 100 microns per second and held for 9hours. For example, the exemplary dressing is able to maintain anengineering stress level of about 350 KPa at an engineering strain of30%. In some other examples, the minimum level of stress may be about100 KPa, about 120 KPa, about 140 KPa, about 160 KPa, about 180 KPa,about 200 KPa, about 220 KPa, about 240 KPa, about 260 KPa, about 280KPa, about 300 KPa, about 320 KPa, about 340 KPa, about 360 KPa, about380 KPa, about 400 KPa, about 420 KPa, about 440 KPa, about 460 KPa,about 480 KPa, about 500 KPa, about 600 KPa, about 700 KPa, about 800KPa, about 900 KPa or about 1000 KPa or greater. The level of constantstrain may be different in other configuration, with a level of about15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%,about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, orabout 80%. The time period over which the dressing is able to maintain astress level may be at least about 2000 seconds, about 3000 seconds,about 4000 seconds, about 5000 seconds, about 6000 seconds, about 7000seconds, about 8000 seconds, about 9000 seconds, about 10000 seconds,about 20000 seconds, about 30000 seconds, about 40000 seconds, about50000 seconds, about 60000 seconds, about 70000 seconds, about 24 hours,about 36 hours, about 48 hours, about 72 hours, about 4 days, about 5days, about 6 days, about 7 days, about 10 days, about 2 weeks, about 1month or more. In some variations, the dressing, the elastic materialand/or the adhesive material is configured to exhibit less than about a15% change in stress or strain level over the particular period whenapplied to a skin surface or test surface. In other examples, the degreeof change may be about 12%, about 10%, about 8%, about 6%, about 5%,about 4%, about 3%, or about 2% or less. The stress or strain may be anengineering stress or strain, and/or a true stress or strain.

The adhesive used may be, for example, a pressure activated adhesive(PSA), as a silicone, acrylic, styrene block copolymer, vinyl ether,nitrile or other PSA. In other variations, a non-pressure sensitiveadhesive may be used, including but not limited a heat or light-curedadhesive. The pressure sensitive adhesive may be made from, e.g.,polyacrylate-based, polyisobutylene-based, silicone-based pressuresensitive adhesives, synthetic rubber, acrylic, and polyisobutylene(PIB), hydrocolloid, and the like. The T-peel release force and bluntprobe tack force of the adhesive may be measured by a standardized testmethod, such as ASTM D1876 and ASTMD2979 or other appropriate method. Insome variations, the T-peel release force or blunt probe tack test valueof the adhesive is configured to maintain loads of at least about 50mPa/mm for at least about 24 hours, about 48 hours, about 72 hours,about 1 week, about 2 weeks, about 3 weeks, about 4 weeks or more. Inother variations, the loads may be at least about 75 mPa/mm, about 100mPa/mm, about 125 mPa/mm, or at least about 150 mPa/mm over theparticular time period. The degree of adhesion (e.g. as measured by theT-peel release force or blunt probe tack test value) may vary dependingupon the degree of strain placed onto the skin or incision site, and insome variations, these time periods may be based upon an average skinstrain of about 10%, about 20%, about 30%, about 40%, or about 50% ormore. In some variations, the adhesive may have a T-peel release forceof at least about 150 kg/m, about 160 kg/m, about 170 kg/m, about 180kg/m, about 190 kg/m, about 200 kg/m, about 210 kg/m, about 220 kg/m,about 230 kg/m, about 240 kg/m, about 250 kg/m, about 260 kg/m, about270 kg/m, about 280 kg/m, about 290 kg/m, about 300 kg/m, about 310kg/m, about 320 kg/m, about 330 kg/m, about 340 kg/m, about 350 kg/m,about 400 kg/m, about 450 kg/m, or at least about 500 kg/m or higher. Insome further variations, the T-peel release force may be no greater thanabout 1000 kg/m, about 900 kg/m, about 800 kg/m, about 700 kg/m, about600 kg/m, about 500 kg/m, about 400 kg/m or about 300 kg/m. The bluntprobe tack test value of the adhesive may be at least about 0.50 kg,about 0.55 kg, about 0.60 kg, about 0.65 kg, about 0.70 kg or about 0.75kg or higher, and may be no greater than about 1 kg, about 0.9 kg, about0.8 kg, about 0.7 kg, or about 0.6 kg. The T-peel release force andblunt probe tack force may be measured by a standardized test method,such as ASTM D1876 and ASTMD2979 or other appropriate method. Otherfeatures or variations of the device are described in U.S. applicationSer. No. 11/888,978, filed on Aug. 3, 2007, incorporated in its entiretyherein by reference.

The release liners may comprise any of a variety of materials, includingboth opaque and transparent materials. The release liners may compriseMylar or paper, or any other material with reduced adhesion to theadhesive material(s) of the device. For example, for a siliconeadhesive, a fluoropolymer-treated polyester film may be used, and for anacrylic pressure sensitive adhesive, a silicone treated polyester orMylar film or silicone treated craft paper may be used. In variationswhere the device has multiple separate adhesive regions, separaterelease liners may be provided for each region, or some regions may becovered by the same release liner.

Examples of dressings, applicators or tensioning devices that may beused in the devices kits or methods herein may include those provided inU.S. application Ser. No. 12/854,859 filed Aug. 11, 2010, the disclosureof which is already incorporated in its entirety herein by referencewithout limitation.

The packaging assembly, applicator and/or tensioning device may comprisea tensioning structure, and a first attachment portion configured toreleasably attach to a dressing and a second attachment portionconfigured to releasably attach to the dressing, wherein the tensioningstructure may be configured to exert a separation force between thefirst attachment portion and the second attachment portion to cause astrain in a dressing attached to the first and second attachmentportions. An elastic dressing may be configured to releasably attach tothe first and second attachment portions of a dressing and packagingassembly and may include an attachment structure or may be integral withattachment structures of a packaging device, applicator or tensioningmember. The tensioning structure may also act as an applicator device ormay be configured to permit a user to apply a dressing to skin of asubject.

Attachment structures of a packaging device, dressing assembly, dressingcarrier, support, base, applicator, tensioning or straining device mayinclude any structures that are used to attach or couple an applicator,tension or straining device to a dressing. A dressing may or may nothave attachment features or structures. Any such attachment features maybe integral with or include any of the attachment structures orcorresponding structures to the attachment structures of the packaging,applicator dressing and/or tensioning device.

In some variations the assembly may comprise one or more mechanisms orelements configured to facilitate separation, release, removal ordetachment of the dressing from the packaging, applicator or tensioningdevice, other attachment elements or other portions of the dressingassembly, including but not limited to the separation devices andmethods described herein. Release elements or releasable attachmentstructures may include but are not limited to pockets and tabs, hook andloop mechanism, hooks, angled bars, pivoting, rolling, rocking orsliding features associated with or coupled to attachment structures,adhesives, removable adhesives, adhesive tapes or other adhesivedevices, pegs, rip cords, towel bar configurations, sliding pins,friction locks, cam locks, vacuum or suction devices, snap connectors,carpet tack, press fit connections or other connections, levers,latches, locking members, spring members, for example, or othermechanisms such as cutters or rip cords or other structures or featuresto facilitate tearing, cutting or separation of attachment structures orelements perforated or otherwise severable structures, that permitremoval of dressing from the applicator, packaging, other portions ofthe dressing assembly and/or attachment structures, features, elementsor portions They may be self-releasing latches or spring members. Theymay be actuated when a pressure member is applied to a skin treatmentdevice prior to removing the applicator. They may be manually actuated.

As noted, a packaging or applicator, tensioning device and/or strainingdevice may be provided in some embodiments to impart a strain to a skintreatment device with an external force and/or to maintain a strainimparted to the skin treatment device. The packaging, applicator ortensioning device may be configured to pivot or rotate to tension thedressing. In some examples, the straining device may be configured toimpart and/or maintain a single predetermined or pre-set strain or aplurality of predetermined or pre-set strains, or predetermined maximumor minimum amounts of strain. Features described herein with respect toa packaging assembly, applicator or tensioning device may also be usedin any device that is used to strain a dressing. A packaging orapplicator, tensioning or straining device that is described as being inan unstrained configuration is in a configuration in which a dressingmay be unstrained or relatively less strained when attached to thepackaging, applicator, tensioning or straining device. A packaging,applicator, tensioning, or straining device that is described herein asbeing in a strained configuration, is in a configuration in which adressing may be strained or relatively more strained when attached tothe packaging, applicator, tensioning or straining device, or withrespect to an unstrained configuration, when applied to a subject'sskin.

Packaging devices, applicators, tensioning devices, and correspondingattachment features may be configured to provide multi-direction strainor additional strain in an orthogonal direction to a dressing.

The packaging device, applicator, tensioning device and/or attachmentstructure profile may be straight, curved or otherwise varied. Forexample, the shape of the elements of a device may be configured tofollow the shape of the area of the subject's body to which the skintreatment device is to be attached. A packaging device, tensioningdevice, applicator or elements thereof may be selected or configured tohave a profile that has a desirable profile for a particular bodylocation or profile where the skin treatment device is to be placed on asubject's skin. A packaging device, applicator, tensioning device orelements thereof may be selected or configured to closely match aportion of a subject's body profile. The packaging device, applicator ortensioning device and/or an element or segment thereof, may be curved,curvable, flexible, bendable, malleable, deformable, shapeable ormovable to provide alternative shapes or profiles of an attacheddressing. They may be relatively curved, curvable, flexible, malleable,bendable, deformable, shapeable or movable in at least one directionwhile being more rigid in another direction.

A variety of locking, latching, securing, attaching or detent mechanismsmay be used to maintain the packaging, applicator or tensioning devicein a various configurations including but not limited to unstrained,partially strained, strained configurations. A variety of locking,latching or detent mechanisms may be used to maintain a dressing in avariety of configurations including unstrained, partially strained,strained. By locking the packaging, applicator, tensioning device, ordressing in a strained position, a predetermined strain of a givendressing may be achieved. The predetermined amount of strain may be apredetermined absolute percentage of strain or level of force that isindependent of the shape and/or size of the treatment site. As a furtherexample, this absolute percentage of strain or level of force may beindependent of the minimum strain or force to achieve sutureless woundclosure (e.g. a relative strain or force to achieve opposition of theincision edges of a treatment site). Furthermore, the force needed toachieve wound closure is not a predetermined strain or force, since thefinal level of strain or force is not known until opposition of theincision edges is achieved.

Referring to FIGS. 1 to 5C, a variation of a dressing and packagingassembly 100 is illustrated. The packaging assembly 100 comprises abook-like applicator and/or tensioning device 120, a dressing assembly110 including a dressing 130, and a release 150 configured to releasethe dressing 130 from the applicator and/or tensioning device 120.

The dressing 130 comprises an elastic sheet 131 with one or moreadhesive regions comprising a layer of skin adhesive 135 on a firstsurface 135 a. The adhesive used may be, for example, a suitablepressure activated adhesive (PSA), or a non-pressure sensitive adhesive.

The packaging assembly 100, applicator or tensioning device 120 and/ordressing assembly 110 may be configured to pre-strain the dressing 130and/or permit transfer of the pre-strained dressing 130 to the skin of asubject. The applicator and/or tensioning device 120 may also providefor a convenient, expeditious or sterile transfer of an adhesive portionof the dressing 130 to a skin and/or wound site of a subject.

The device 120 comprises a cover 121 and a base 122. The dressingassembly 110 is removably coupled or anchored to the device 120 whichmay act as a dressing carrier or a support. The cover 121 may begenerally planar and include sides 123, 124 with corresponding edges 123a, 124 a along its length, and edges 121 a at opposing ends. Thedressing carrier or base 122 may be generally planar and include sides125, 126 with corresponding edges 125 a, 126 a along its length andedges 122 a at opposing ends.

According to some variations, the cover and/or base 121,122 or elementsor segments thereof may be constructed to be sufficiently firm or rigidor less flexible relative to an attached dressing to support an attacheddressing until it is applied to a subject as described with respect tothe variations herein. Such material may comprise, for example, aplastic, e.g., polypropylene, polycarbonate, polytetrafluoroethylene(PTFE or TEFLON®), LDPE, high-density polyethylene (HDPE), ultrahigh-molecular weight polyethylene (UHMWPE), polyvinyl chloride (PVC) oracrylic, nylon or a paperboard. The elements or segments may be alaminate of a material, such as a solid bleach sulfate paperboard with alayer of flexible material between layers of paperboard, for example,silicone, polyurethane, LDPE or a rubber material. The material may alsobe a metal as for example, ductile aluminum or stainless steel. Themetal may comprise a foil, ribbon, wire or other form.

Cover 121 and base 122 are movably, hingedly or pivotably coupled atsides 123, 125. For example, a layer of material such as silicone,polyurethane, low-density polyethylene or a rubber material may be gluedto each of the cover and base, flexibly attaching them together at sides123, 125. Alternative devices and methods may be used to couple thecover 121 and base 122. For example, various composite structures orlaminates may be used. Also devices may be constructed out of a singlesubstrate that provides flexibility in some selected regions andrigidity in others, or a relative or absolute flexibility in a firstdirection with a relative or absolute rigidity in a second directionthat may be transverse to the first direction. Although the cover 121and base 122 depicted in FIGS. 1 to 5C have generally the same size andshape, in other examples, the cover 121 and base 122 may be differentsizes and/or shapes. Cover 121 and/or base 122 may be bendable,foldable, curvable, flexible, malleable or shapeable permittingrelatively more even placement on a location with a varying shape orcurvature. For example, cover and base 121, 122 as illustrated are eachdivided into segments 127 along lengths that are bendable or movablewith respect to adjacent segments, permitting flexibility of the device120 along its length. The segments 127 may be constructed of a morerigid material that reduces flexion in a widthwise or other direction.Other configurations that vary the directions of rigidity and/orflexibility may be use. Configurations may include providing rigidity ina direction in which a dressing is strained that is sufficient to createand/or maintain a desired level of strain. The segments 127 may becoupled by a material, such as an elastomer, e.g., silicone thatflexibly holds the segments together in relationship to each other.Other construction may also be used to flexibly couple segments or otherelements. The material coupling or binding the cover and base 121, 122,may or may not be continuous with the material that couples the segments127 to adjacent segments 127, and may or may not be attached to all or aportion of a side of cover and base 121, 122. The various attachedstructures, e.g. the segments and/or the cover and base and couplingelements may provide a structural support for the dressing carrier to bemanipulated by a user. Margins between at least a portion of thestructural support elements, dressing carrier or backing, and thedressing may be provided at or near edges 121 a, 123 a, 124 a, 122 a,125 a, and/or 126 a, for example as described further herein. In somefurther embodiments, the material attaching the cover 121 and base 122may comprise a semi-rigid structure that may be biased to an open or aclosed configuration, or a configuration therebetween. In still othervariations, the cover 121 and base 122 may be attached by any of avariety of articulations, including but not limited to one or more apin-based hinge joints, rings attached to holes in the cover 121 andbase 122, or ball-and-socket joints.

As exemplified in FIGS. 5A-5C, a variation of construction of a packageis shown. Cover 121 and base 122 comprise relatively firm or rigidelements, for example battens 121 a, 121 b and battens 122 a, 122 brespectively that are attached by way of a sheet 128 of material, suchas, e.g., silicone, polyurethane, low-density polyethylene or a rubbermaterial that also flexibly couples cover and base 121, 122 at sides123, 125. Segments 127 may have alternative shapes and constructioncoupling the segments 127 together. Thus, the device 120 may beconstructed to bend or curve to varied extents or in multipledirections. Accordingly, a device may be constructed to be used on aspecific anatomical location or with varying sizes, or may beconstructed to have a shape for a particular situation or individual.

According to some variations each of the cover 121 and base 122 isconstructed at least in part of a clear plastic, semi-opaque or othermaterial that provides a window portion 159 through which a wound,incision, or other location may be visualized for accurate placement ofthe dressing 130. The cover 121 and base 122 may or may not comprise thesame material. The elastic sheet 131 and adhesive layer 135 may also besufficiently clear to permit visualization through them. A more opaquematerial may be provided on portions of the material to createboundaries of a window 159. The segments 127 may be clear or semi-opaqueto provide the window for viewing, positioning, and/or centering thelocation of a wound or position on skin with respect to the dressing 130or for positioning the wound within an optimal or most effective strainzone of the dressing. The boundaries or other markings may assist a userin placing the dressing 130 in an appropriate position over the wound orincision.

The dressing 130 of the dressing assembly 110 has a first side or edge133 having a length, and a second side or edge 134 having a length. Thedressing 130 is coupled to the packaging assembly 100 along the lengthsof the dressing's sides 133, 134. When the device 120 is closed, theadhesive layer 135 faces away from the base 122 and is covered by arelease liner 149 that is attached to the inside surface 177 of thecover 121. The dressing assembly 110 also includes an attachment sheet141 having a first side 143 and a second side 144. The attachment sheet141 couples the dressing 130 to the cover of the device 120 which whenopened, exerts a straining force on the dressing 130 through theattachment sheet 141. According to some variations, the attachment sheet141 is flexible while being relatively inelastic with respect to thedressing 130 and may be constructed, e.g., out of a low densitypolyethylene. When assembled, the attachment sheet 141 is bonded to theelastic sheet 131 of the dressing at (for example, using a combinationof a silicone PSA/acrylic PSA) or near the sides 134 and 143 of thedressing 130 and attachment sheet 141 respectively. The attachment sheet141 is coupled at its side 144 to the cover 121 at attachment points 137defining a line or area of attachment 137 a along the length of thecover 121. The dressing 130 is coupled to the second side 124 of thebase 122 at a location near the first side 133 of the dressing 130. Assuch, the elastic sheet 131 is attached at attachment points 138defining a line or area of attachment 138 a along a length of the base122. A number of bonding methods or adhesives may be used to attach theattachment sheet 141 to the cover 121, for example, a low surface energyPSA such as an acrylic adhesive.

When the assembly 100 is in a closed configuration as illustrated inFIG. 1 and at an open 90 degree configuration as shown in FIG. 2, theelastic sheet 131 is relaxed or unstrained, with the elastic sheet 131having an unstrained width w1. As the assembly 100 is opened to 180degrees or up to about 360 degrees (e.g. by rotating or pivoting thecover 121 with respect to the base 122), the orthogonal distanceincreases between lines or areas of attachment 137 a, 138 a. Accordingto some variations the assembly is opened to no less than about 180degrees (minimum angular change) to provide for application of adressing without interference of the assembly 100. When the device 120is opened, it exerts a separation force between attachment regionsdefined by attachment lines or areas 137 a, 138 a or correspondingattachment areas. The force tensions the elastic sheet, creating astrain. Tensioning and imparting a strain on the dressing 130 increasesthe width between attachment lines or areas 137 a, 138 a to w2. Theincrease in the width, i.e., w2 minus w1, may be a percentage of w1 or apercent strain as described herein. While straining is illustrated asstarting when the cover 121 is opened about 90 degrees from the base122, the dressing 130 may be attached to the cover 121 at a number oflocations or in a number of configurations that may vary the coverposition or configuration at which straining begins. The edge 124 a orside 124 of the cover 121 may act as a lever arm to provide a mechanicaladvantage, which may depend, among other things, on the distance of thepoint of attachment 138 of the dressing assembly 110 on the cover to theedge 124 a of the cover 121 as well as the angle of the cover 121 withrespect to the base 122 at which the tensioning of the dressing occurs.Additionally, the point of attachment 138 of the inelastic attachmentsheet 141 to the cover 121 may determine amount of strain applied to thedressing, assuming among other things, the length of the attachmentsheet 141 remains the same and the point of attachment 137 of thedressing assembly 110 to the base 122 remains the same

According to one variation, the dressing 130 may be substantially fixedat one edge, (e.g. at edge 134 at the side 126 of the base 122) whilenot being fixed at an opposite edge (e.g., edge 133 moves when strainedwith respect to edge 125 a of base 122). When the cover 121 is openedand the dressing 130 is strained, the width of the strained dressing maybe less than the width of the base 122 and/or the cover 121 so that thearea of the dressing is located over the area of the base 122 and or thecover 121, i.e. the base 122 and/or cover 121 margins outside of thearea of the dressing. According to other variations the dressing may befixed at both edges.

According to some variations, the dressing is sufficiently large withrespect to the device 120 so that when applied to the skin, there isrelatively less interference by the device 120. According to oneexample, the width of the strained portion of the dressing may be about10 mm, about 20 mm, about 30 mm, about 40 mm, or about 50 mm. Otherstrained dimensions may be used. According other variations, thedistance between each of edges 133, 134 of the dressing 130 and theedges 125 a, 126 a of the base 122 respectively (and/or the edges 123 a,124 a of the cover 121) is no greater than about 10 mm, 15 mm or 20 mm.According to some variations, the distance between the edges 136 a, 136b of the dressing and the edges 122 a of the base is no greater thanabout 10 mm, about 15 mm or about 20 mm.

According to some variations, edges 133, 134, 136 a, 136 b of thedressing 130 are at least about 1.0 mm inward of at least a portion ofthe edges 125 a, 126 a, and/or 122 a of the base 122 so that the edges125 a, 126 a, and/or 122 a of the base 122 may be gripped by a user witha reduced likelihood of touching the dressing 130 or the adhesive layer135. According to some variations, the ends 136 a, 136 b of the dressing130 have a margin of at least about 1.0 mm inward of the ends 122 a ofthe base 122. According to some variations the sides 133, 134 and ends136 a, 136 b of the dressing 130 have a margin of about 10 mm from thesides 125, 126 and ends 122 a of the base respectively. According tosome variations the sides 133, 134 and ends 136 a, 136 b of the dressing130 have a margin of about 15 mm from the sides 125, 126 and ends 122 aof the base respectively. Each of the margins between sides 133,134 orends 136 a, 136 b of the dressing 130 and sides 125, 125, and ends 122 aof the base 122 may be different. As illustrated in FIG. 3, for example,margins m1 and m2 are about no less than 3 mm and margin m3 is about 15mm. Similar margins may be provided between the dressing 130 and theedges 121 a, 123 a, and/or 124 a of the cover 121, for example if theedges of the cover 121 are used alternatively or additionally to graspthe device 120 or manipulate the dressing 130. Then, once the cover 121is opened and the adhesive layer 135 is exposed, the adhesive side ofthe dressing 130 may be placed on a skin or wound site using the device120. As shown in FIGS. 3 and 4 the cover 121 and base 122 may be rotatedan additional amount, with respect to each other, e.g., up toapproximately 360 degrees from the closed configuration prior toapplying the dressing 130. A locking mechanism may optionally beprovided to lock or secure the device in an open, partially opened orclosed position. In some examples, the locking mechanism may comprisemagnets, hook-and-look attachment structures, snaps, latches, clips andthe like.

The adhesive layer 135 of the elastic sheet 131 is protected by arelease liner 149 before the applicator or tensioning device 120 isopened. The release liner 149 is attached or glued to the inside surface177 of the cover 121 so that when the cover 121 is opened as shown inFIG. 2, and is separated from the base 122 (prior to straining theelastic sheet 131), the release liner 149 is pulled away from theelastic sheet 131 exposing the adhesive layer 135. Alternatively, asshown in FIG. 6, a release liner 149 a may be provided on the adhesivelayer 135 that is not attached to the cover 121. When the device 120 isopened, and prior to straining the dressing 130, the release liner 149 amay be manually removed from the elastic sheet 131 to expose theadhesive layer 135.

After the dressing 130 is strained, and the liner 149 or 149 a isreleased, the dressing 130 may be applied to a desired location on asubject's skin. The window 159 may be used to visualize properplacement. The user may apply pressure to the back side 129 of thedevice 120 to activate the adhesive on the elastic sheet 131 and/or toapply compression to a wound. Alternatively, if the cover 121 is rotatedto 360 degrees, pressure may be applied to the inside 177 of the cover121. Once applied to a subject, the elastic sheet 131 may be releasedfrom the packaging, applicator or tensioning device 120 using a releasestructure or mechanism 150.

The release mechanism 150 may comprise cutters 151 each positioned onopposite sides 133, 134 of the elastic sheet 131. Each cutter 151comprises a blade 152 on one end 153 with legs 154, 155 extending toopposing pull tab or tabs 156 on an opposite end 157. The blade 152comprises a sharp surface that may be generally v-shaped or otherwiseshaped. The blade may be constructed, e.g., of stainless steel, ceramicor hard plastic. The blade 152 and the pull tabs 156 each extend proudof the ends 136 a, 136 b of elastic sheet 131, respectively and ends 122a of the base 122. Cutters 151 are attached to the dressing assembly 110in a manner that defines general cutting paths 162, 163 (depicted bestin FIG. 5A) along which the blades 152 are pulled by tabs 156 to cut thedressing assembly 110 to release the dressing 130. In some variations,the dressing may be scored, perforated or otherwise configured tofacilitate separation by the release mechanism.

As best shown in FIGS. 5B and 5C, tubes 164, 165 for receiving andguiding legs 154, 155 respectively of a cutter 151, are positioned alongthe side 133 of the elastic sheet 131. The tubes 164, 165 may bepositioned so that the cutting path 162 is between the tube 164 and thetube 165. The tube 165 is coupled, e.g., glued to the adhesive surface135 of the elastic sheet 131 at a location closer to the side 133 thanthe cutting path 162. The tube 164 is coupled to the back surface 139 ofthe elastic sheet 131 by way of the attachment sheet 141, which is alsocoupled to the elastic sheet 131 at a location closer to the side 133than the cutting path 162. The tube 164 is coupled to a free end 145 ofthe attachment sheet 141 that extends inward of the cutting path 162with respect to the side 133. Thus, the tube 164 may be positionedinside of the cutting path 162 without being attached to the elasticsheet 131 inside of the cutting path 162. This allows the dressing 130to be released from the remainder of the packaging assembly 100including the cutter 151 with tube 164 and attachment sheet 141. Aprotective member 170 is attached, e.g. glued to the top of tube 165.The protective member 170 includes a ledge 171 that extends over thecutting path 162 so that when the adhesive layer 135 is positioned onthe skin of a subject and the cutter 151 is actuated, the skin isprotected from the blade 152.

Tubes 174, 175 for receiving and guiding legs 154, 155 respectively arepositioned along the side 134 of the elastic sheet 131. The tubes 174,175 are positioned so that the cutting path 163 is between the tube 174and the tube 175. The tube 175 is coupled, e.g., glued to the adhesivesurface 135 of the elastic sheet 131 at a location closer to the side134 of elastic sheet 131 than the cutting path 163. The tube 174 iscoupled to the back surface 139 of the elastic sheet 131 by way of theextender sheet 146. The tube 174 is coupled to a free end 147 of theextender sheet 146 that extends inward of the cutting path 163 withrespect to the side. Tube 174 is also coupled to the elastic sheet 131at a location closer to the side 134 than the cutting path 163. Thus thetube 174 may be positioned inside of the cutting path 163 without beingattached to the elastic sheet 131 inside of the cutting path 163. Thisallows the dressing 130 to be released from the remainder of thepackaging assembly 100 including the cutter 151 with tube 175 andextender sheet 146. A protective member 170 is attached, e.g., glued tothe top of tube 175. The protective member 170 includes a ledge 171 thatextends over the cutting path 163 so that when the adhesive layer 135 ispositioned on the skin of a subject and the cutter 151 is actuated, theskin is protected from the blade 152.

The inside of the tubes 164, 165, 174, 175 may be coated with alubricious material, e.g. with Kapton tape. The guiding legs 154, 155may be constructed of a low friction material such as, e.g., HDPE orUHMWPE, so the legs 154, 155 may readily slide in the tubes 164, 165,174, 175 to permit smooth cutting of the dressing 130 from the remainderof the packaging assembly 100.

When the dressing 130 is strained and the adhesive 135 is exposed, thedressing 130 may be applied with the adhesive side 135 towards the skinof a subject. The side 133 of the elastic sheet may then be releasedfrom the applicator by pulling the tabs 146 to draw the blade 152 acrosscutting path 162. Also, the side 134 of the elastic sheet may then bereleased from the applicator by pulling the tabs 146 to draw the blade152 across cutting path 163. Thus the elastic sheet 131 is released fromthe packaging 100 (including the release 150).

Referring to FIGS. 7 to 9, another variation of a dressing and packagingassembly 200 is illustrated. The packaging assembly 200 comprises anapplicator and/or tensioning device 220 and a dressing assembly 210including a dressing 230. The dressing 230 comprises an elastic sheet231 with one or more adhesive regions comprising a layer of skinadhesive 235. The adhesive used may be, for example, a suitable pressureactivated adhesive (PSA), or a non-pressure sensitive adhesive.

The packaging assembly 200, applicator or tensioning device 220, and/ordressing assembly 210 may be configured to pre-strain the dressing 230and/or permit transfer of the pre-strained dressing 230 to the skin of asubject. The applicator or tensioning device 220 may also provide for aconvenient sterile transfer of an adhesive portion of the dressing to askin and/or wound site of a subject.

The device 220 may comprise a cover 221 and a base 222. The dressingassembly 210 is removably coupled or anchored to the device 220, and mayserve as a dressing carrier. The cover 221 may be generally planar andinclude sides 223, 224 with corresponding edges 223 a and 224 a definingits length and edges 221 a at opposing ends. The base 222 may begenerally planar and include sides 225, 226 with corresponding edges 225a and 226 a defining its length and edges 222 a at opposing ends.

According to some variations, the cover and/or base 221,222 or elementsor segments thereof may be constructed to be sufficiently firm or rigidor less flexible relative to an attached dressing to support an attacheddressing until it is applied to a subject as described with respect tothe variations herein. Such material may comprise, for example, aplastic, e.g., polypropylene, polycarbonate, PTFE, LDPE, HDPE, UHMWPE,PVC or acrylic, nylon or a paperboard. The elements or segments may be alaminate of a material, such as a solid bleach sulfate paperboard with alayer of flexible material between layers of paperboard, for example,silicone, polyurethane, low-density polyethylene or a rubber material,The material may also be a metal as for example, ductile aluminum orstainless steel. The metal may comprise a foil, ribbon, wire or otherform. The other variations as described for application or tensioningdevice 100 may be applied to device 200 also.

The cover and base 221 and 222 may be movably, pivotably, bendably orhingedly coupled at sides 223, 225 in a manner similar to that describedwith respect to cover and base 121, 122 herein and may be constructed ina manner similar to cover and base 121, 122 herein, among other things,with segments 227 similar to segments 127 and dressing 230 attached todevice 220 and strained by device in a similar manner as dressing 130 isattached to device 120.

The various attached structures, e.g. the segments and/or the cover andbase and coupling elements may provide a structural support for thedressing carrier to be manipulated by a user. Margins between at least aportion of the structural support elements, dressing carrier or backingand the strained or unstrained dressing may be provided at or near edges221 a, 223 a, 224 a, 222 a, 225 a, and/or 226 a, such as, for example,margins m1, m2, m3 shown in FIG. 3 herein.

According to some variations, each of the cover 221 and base 222 isconstructed at least in part of a clear plastic, semi-opaque or othermaterial that provides a window portion 259 through which a wound,incision or other location may be visualized for accurate placement ofthe dressing 230. The cover 221 and base 222 may or may not comprise thesame material. The elastic sheet 231 and adhesive layer 235 may also besufficiently clear to permit visualization through them. A more opaquematerial may be provided on portions of the material to createboundaries of a window. Segments 227 may be clear or semi-opaque toprovide a window for viewing, positioning, and/or centering the locationof a wound or position on skin with respect to the dressing 230 or forpositioning the wound within an optimal or most effective strain zone ofthe dressing. The boundaries or other markings may assist a user inplacing the dressing in an appropriate position over the wound orincision.

The dressing assembly 210 also includes an attachment sheet 241,attachment sheet 251, and a dressing release structure or mechanism 250comprising pull tabs 246 as described in more detail herein. Thedressing 230 of the dressing assembly 210 has a first side 233 having alength, and a second side 234 having a length. When the device 220 isclosed, the adhesive layer 235 faces away from the base 222 and iscovered by a release liner 249 that is attached to the inside surface277 of the cover 221.

The attachment sheet 241 has a first side 243 and a second side 244. Theattachment sheet 241 couples the dressing 230 to the cover 221 of thedevice 220 near the second side 234 of the dressing 230. The cover 221,when opened, exerts a straining force on the dressing 230 through theattachment sheet 241. The attachment sheet 241 is coupled at its side244 to the cover 221 at attachment points 237, which may be provided asan attachment line or area 237 a, for example, by bonding with a lowsurface energy PSA such as an acrylic adhesive. When assembled, theattachment sheet 241 is bonded to the elastic sheet 231 of the dressing230 at section 265 of attachment sheet 241 at or near the side 243 ofthe attachment sheet 241, for example, using a combination of a siliconePSA/acrylic PSA. The attachment sheet 251 has a first side 253 and asecond side 254. The attachment sheet 251 couples the dressing 230 tothe base 222 of the device 220 near the first side 233 of the dressing230. The attachment sheet 251 is coupled at its side 254 to the base 222at attachment points 238 defining the attachment line or area 238 a, forexample, by bonding with a low surface energy PSA, such as an acrylicadhesive. When assembled, the attachment sheet 251 is bonded to theelastic sheet 231 of the dressing at section 265 of attachment sheet 251at or near the side 253 of the attachment sheet 251, for example, usinga combination of a silicone PSA/acrylic PSA.

Dressing 230 has unattached portions or edges 255 at its sides 233, 234where the elastic sheet 231 is free from the attachment sheets 241, 251respectively. Accordingly, the dressing 230 is not strained atunattached portions 255. The pull tabs 246 are each coupled to ends 281,282 of the device 220. Each pull tab 246 comprises a top section 247 andbottom section 248. The bottom sections 248 are attached to the base 222or cover 221 as illustrated while top sections 247 are adjacent butunattached to the dressing 230.

According to some variations, the attachment sheets 241, 245 areflexible while being relatively inelastic with respect to the dressing230 and may be constructed, e.g., out of a low density polyethylene. Theattachment sheets 241, 245 may be manufactured to be tearable along thematerial length while providing tensile strength in other directions, inparticular in the tensioning direction of the material of the attachmentsheet 241 (direction in which dressing is tensioned, stressed orstrained). An example of such material is an LDPE polymer which isproduced by an extrusion process that creates a directionally biasedgrain whereby the material is tearable with the direction of the grain,but has a relative resistance to tearing in the direction transverse tothe grain. The pull tab 246 may start a tear at a notch in theattachment sheet 241 or 251 that is to be completed along lines 262. Theattachment sheets 241, 251 may additionally or alternatively comprise amaterial such as an LDPE with perforations formed along tear lines 262.

Similar to assembly 100 herein, when the assembly 200 is in a closedconfiguration and at an open 90 degree configuration as shown in FIG. 7,the elastic sheet 231 is relaxed or unstrained, with the elastic sheet231 having an unstrained width w3. As the assembly 200 is opened to 180degrees or up to 360 degrees (e.g. by rotating or pivoting the cover 221with respect to the base 222), the orthogonal distance increases betweenlines or areas of attachment 237 a, 238 a. When the device 220 isopened, it exerts a separation force between attachment regions definedby attachment lines or areas 237 a, 238 b or corresponding attachmentareas. The force tensions the elastic sheet 231 creating a strain.Tensioning and imparting a strain on the dressing 230 increases thewidth between attachment lines or areas 237 a, 238 a to width w4. Theincrease in the width (i.e. width w4 minus width w3) may be a percentageof w3 or a percent strain as described herein. While straining isillustrated as starting when the cover 221 is opened about 90 degreesfrom the base 222. The dressing 230 may be attached to the cover 221 ata number of locations or in a number of configurations that may vary atwhich position or configuration the cover 222 may be when the strainingbegins.

As shown in FIGS. 8 to 8B, the cover 221 and base 222 may be rotated anadditional amount, with respect to each other, e.g., up to approximately360 degrees from the closed configuration prior to applying the dressing230. According to some variations the assembly is opened to no less thanabout 180 degrees (minimum angular change) to provide for application ofthe dressing without interference from the assembly.

Then, once the cover 221 is opened and the adhesive layer 235 isexposed, the adhesive side of the dressing 230 may be place on a skin orwound site using the device 220. The cover 221 and base 222 may berotated an additional amount, with respect to each other, e.g., up toapproximately 360 degrees from the closed configuration prior toapplying the dressing 230. The orientation of the cover 221 at which thedressing 230 begins to strain may be varied, e.g. by varying theattachment location of the dressing assembly 210 to the cover 221. Alocking mechanism may optionally be provided to lock or secure thedevice in an open, partially opened or closed position. In someexamples, the locking mechanism may comprise magnets, hook-and-loopattachment structures, snaps, latches, clips and the like.

The adhesive layer 235 of the elastic sheet 231 is protected by arelease liner 249 before the applicator and tensioning device 220 isopened. The release liner 249 is attached to the inside surface 277 ofthe cover 221 so that when the cover 221 is opened and is separated fromthe base 222, (prior to straining the elastic sheet 231) the releaseliner 249 is pulled away from the elastic sheet 231 exposing theadhesive layer 235 prior. Alternatively, as shown in FIG. 6, a releaseliner 149 a may be provided on the adhesive layer 235 that is notattached to the cover 221. When the device 220 is opened, but prior tostraining, the release liner 149 a may be manually removed from theelastic sheet 231 to expose the adhesive layer 235.

After the liner 249 or 149 a is released and the dressing 231 isstrained, the dressing 230 may be applied to a desired location on asubject's skin. The window may be used to visualize proper placement.The user may apply pressure to the back side 229 of the device 220 toactivate the adhesive on the dressing 231 and/or to apply compression toa wound. If the cover 221 is rotated to 360 degrees, pressure may beapplied to the inside 277 of the cover 221. Once applied to a subject,the dressing 230 may be released from applicator or tensioning device220 using the release mechanism 250.

The pull tabs 246 of the release mechanism 250 each extend proud of theend 236 a of elastic sheet 231. Each release pull tab 246 is attached tothe dressing assembly 110 in a manner that defines tear paths 262 alongwhich the tabs 246 are pulled to separate the dressing 230 from thedevice. Notches or perforations may be made in the attachment sheets241, 251 that facilitate tearing along paths 262.

The dressing 230 is applied to a subject. The dressing 230 may then bereleased from the device 220 by pulling the tabs 246 to draw the tabs246 across paths 262 of the attachment sheets 241, 251. The sections 245of the attachment sheets 241, 251 that bonded to the pull tabs 246 arethereby separated from the attachment sheets thereby separating thesections 265 of the attachment sheets that are attached to the dressing230 are from the remainder of the attachment sheets 241 and 251 that areattached to the cover 221 and base 222 respectively. Thus, the dressing230 is released from the remainder of the packaging 100 as shown in FIG.9. Sections 265 of the attachment sheets 241, 251 may remain on the backsurface 239 of the silicone sheet 231 as shown in FIG. 9. Unattachedsections 245 of the elastic dressing 230 are unstrained and may be freefrom the adhesive of the adhesive layer 235 (or may have a reducedamount of adhesive thereon). Thus less stress occurs at the unattachedsides or edges defined by sections 245.

Referring to FIGS. 10 to 12B, a dressing and packaging assembly 300 isillustrated. The packaging assembly 300 comprises a packaging deviceapplicator 320 and a dressing assembly 310 including a dressing 330.

The packaging device or applicator 320 is configured to permit transferof the dressing 330 to the skin of a subject and may also provide for aconvenient, expeditious or sterile transfer of an adhesive portion ofthe skin treatment device to a skin and/or wound site of a subject.

The packaging device or applicator 320 comprises a cover 321 and abottom element, dressing carrier or base 322, to which dressing assembly310 is removably coupled or anchored. The cover 321 may be generallyplanar and include sides 323, 324 with corresponding edges 323 a, 324 adefining its length and edges 321 a at opposing ends. The base 322 maybe generally planar and include side 325, 326 with corresponding edges325 a, 326 a defining its length and edges 322 a at opposing ends.

According to some variations, the cover 321 and base 322 are constructedin part of a relatively inflexible material, e.g., with respect to anattached dressing 330. Such material may comprise, for example, aplastic, paperboard or a laminate of a material, or metal as describedherein with reference to cover 121 and base 122. The cover or base maybe constructed in a manner as described, for example, with respect tothe various applicator, tensioning devices or dressing carriers shown inFIGS. 1 to 22B herein. The cover 321 and base 322 may or may notcomprise the same material.

Cover 321 and base 322 may be movably, pivotably, bendably or hingedlycoupled at sides 323, 325 and otherwise constructed in a manner similarto that described herein with respect to cover 121 and base 122. Thepackaging device or applicator 320 may include a window portion 359through which a wound, incision, or other location may be visualized foraccurate placement of the dressing 330 in a manner similar to thatdescribed herein with respect to the use of windows 159, 259.

The assembly 300 is constructed including a dressing assembly 310 with askin dressing device 330. The dressing assembly 310 also includes adressing release structure or mechanism 350 which may be a releasedevice such as various release and removal structures described hereinwith reference to FIGS. 1 to 22B. The dressing 330 may comprise avariety of dressing materials, including but not limited to elasticbandages, gauze type bandages, hydrocolloids. The various structures,e.g. the segments and/or the cover and base and coupling elements mayprovide a structural support for the dressing carrier to be manipulatedby a user. Margins between at least a portion of the structural supportelements, dressing carrier or backing and the dressing may be providedat or near edges 321 a, 323 a, 324 a, 322 a, 325 a, and/or 326 a, forexample as described herein.

When assembled with the packaging device or applicator 320, the dressing330 is coupled to the base. A length of the dressing 330 adjacent itsfirst side 333 is bonded to a length of the base 322 adjacent its side324 and outside of release 350. Also a length of the dressing 330adjacent its second side 334 is coupled to a length of the base 322adjacent its side 325 and outside of release 350. An attachment sheetsimilar to sheets 141, 146 or 241, 251 may be used to attach sides 333,334 of dressing 330 to the base 322. The adhesive layer 335 faces awayfrom the cover 321 and base 322 when the applicator 320 is opened.

According to variation, the dressing 330 is sufficient large withrespect to the device 320 so that when applied to the skin, there isrelatively less interference by the device 320. According to oneexample, the width of the strained portion of the dressing may be about20 mm, about 30 mm, about 40 mm, or about 50 mm. According othervariations, the distance between each of edges 333 a, 334 a of thedressing 330 and the edges 325 a, 326 a of the base 322 respectively(and/or the edges 323 a, 324 a of the cover 321) is no greater thanabout 10 mm, 15 mm or 20 mm. According to variations the distancebetween the edges 336 a, 336 b of the dressing and the edges 322 a ofthe base is no greater than about 10 mm, about 15 mm or about 20 mm.

According to some variations, edges 333, 334, 336 a, 336 b of thedressing 330 are at least about 3 mm inward of at least a portion of theedges 325 a, 326 a, and/or 322 a of the base 322 so that the edges 325a, 326 a, and/or 322 a of the base 322 may be gripped by a user with areduced likelihood of touching the dressing 330 or the adhesive layer335. According to some variations, the ends 336 a, 336 b of the dressing130 have a margin of at least about 3 mm inward of the ends 322 a of thebase 322. According to some variations the sides 333, 334 and ends 336a, 336 b of the dressing 330 have a margin of about 10 mm from the sides325, 326 and ends 322 a of the base respectively. According to somevariations the sides 333, 334 and ends 336 a, 336 b of the dressing 330have a margin of about 15 mm from the sides 325, 326 and ends 322 a ofthe base respectively. Each of the margins between edges 333,334 or ends336 a, 336 b of the dressing 330 and sides 325, 325, and ends 322 a ofthe base 322 may be different. As illustrated in FIG. 3, for example,margins m1 and m2 are about no less than 3 mm and margin m3 is about 15mm. Similar margins may be provided between the dressing 330 and theedges 322 a, 325 a, and/or 326 a of the base 322, Also similar marginsmay be provided between the dressing 330 and the edges 321 a, 323 a,and/or 324 a of the cover 321, for example if the edges of the cover 321are used alternatively or additionally to grasp the device 320 ormanipulate the dressing 330.

The adhesive layer 335 on the dressing 330 may be protected by a releaseliner 349 before the packaging device or applicator 320 is opened. Therelease liner 349 may be attached to the inside surface 377 of cover 321so that when the cover 321 is opened or is separated from the base 322,the release liner 349 is pulled away from the dressing 330 exposing theadhesive layer 335. The release liner 349 may also be a protective linerthat protects or covers the dressing prior to application. For example,the liner may cover a dressing to which a substance or medicament orother agent is applied. One or more hemostatic or coagulative agents maybe applied to, or otherwise integrated with dressing to help reducebleeding. Potential agents include chitosan, calcium-loaded zeolite,microfibrillar collagen, cellulose, anhydrous aluminum sulfate, silvernitrate, potassium alum, titanium oxide, fibrinogen, epinephrine,calcium alginate, poly-N-acetyl glucosamine, thrombin, coagulationfactor(s) (e.g. II, VII, VII, X, XIII, Von Willebrand factor),procoagulants (e.g. propyl gallate), antifibrinolytics (e.g. epsilonaminocaproic acid), and the like. In some variations, the agents may befreeze-dried and integrated into the dressing and activated upon contactwith blood or other fluid. In some further variations, an activatingagent may be applied to the dressing or the treatment site before thedressing is used on the subject. In still other examples, the hemostaticagent may be applied separately and directly to the wound beforeapplication of the dressing, or after application to the dressing via acatheter or tube. The devices may also comprise one or more other agentsthat may be any suitable agent that may be useful in aiding in someaspect of the wound healing process. For example, the active agent maybe a pharmaceutical compound, a protein (e.g., a growth factor), avitamin (e.g., vitamin E), or combinations thereof. Of course, thedevices may comprise more than one medicament or agents, and the devicesmay deliver one or more medicaments or agents. An example of suchmedicament may include, but is not limited to various antibiotics(including but not limited to cephalosporins, bactitracin, polyxyxin Bsulfate, neomycin, polysporin), antiseptics (such as iodine solutions,silver sulfadiazine, chlorhexidine), antifungals (such as nystatin),antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus,paclitaxel), grow factors (such as VEGF) and other treatments (e.g.botulism toxin). The cover 321 may be pulled away or separated in anumber of manners. The cover 321 may be opened like a cover of a book.Similar to devices 120 and 220, 420, 520, 620, 720, 820, 920, 1020herein, the elements 321, 322 may be rotated sufficiently to separatethe release liner 349 and up to approximately 360 degrees allowing theexposed adhesive side 335 of the dressing 330 to be place on a skin orwound site using the packaging device or applicator 320. According tosome variations the assembly 300 is opened to no less than about 180degrees (minimum angular change) to provide for application of thedressing without interference of the assembly 300. Alternatively, forexample, the cover 321 may be attached to the base 322 by an adhesiveand may be peeled off of the dressing 330 or the base 322 to which thedressing 330 is coupled. The cover 321 itself may be a removable, orseparable release liner that may be peeled from the base 322.Alternatively, as shown in FIG. 6, a release liner 149 a may be providedon the adhesive layer 335 that is not attached to the cover 321. Whenthe device is opened, the release liner 149 a may be manually removedfrom the dressing 330 to expose the adhesive layer 335. In such case,the cover 321 may be omitted. After the device 300 is opened to positionshown in FIG. 11 or 12A and 12B, the dressing 330 may be applied to adesired location on a subject's skin. The window 359 may be used tovisualize proper placement. A locking mechanism may optionally beprovided to lock or secure the device in an open, partially open, orclosed position. In some examples, the locking mechanism may comprisemagnets, hook-and-look attachment structures, snaps, latches, clips andthe like as well as adhesives, or other adhesive structures. Acompressive force may be applied to the back side 378 of base 322 orinside 377 of cover if rotated approximately 360 degrees. Once appliedto a subject, the dressing 330 may be released from packaging device orapplicator 320 using a release mechanism 350. The release mechanism 350may include a cutting element or a perforated element as described forexample with respect to devices 150 and 250 herein. The releasemechanism may further include one more release elements described hereinand show in FIGS. 1 to 22B.

FIG. 13 illustrates an alternative packaging or applicator 420 that maybe used in any of the embodiments herein including device elements orfeatures that may be substituted for device elements or features ofdevices 120, 220 or 320, 520, 620, 720, 820, 920, 1020, 1120, 1220. FIG.13 illustrates a cover 421 and a dressing carrier or base 422 that areconstructed of a single substrate out of a material such as nylon and/orpolyethylene or a metal. The device 420 may be manufactured from asingle mold and/or may have portions cut out of the substrate, slots,grooves, scoring or other openings or variations in thickness of thesubstrate at different locations. The cover 421 and base 422 eachcomprise slots 428 that form elements such as segments 427. The slots428 permit flexion of the device 420 allowing it to conform to asubject's body contours where an attached dressing is to be applied.Cover 421 and base 422 are coupled to each other by way of connectionfeatures 429 that are formed in the substrate. The cover 421 and base422 are hingedly or pivotably moveable with respect to each other byvirtue of slots 430 that are formed adjacent connection features 429, topermit flexion or movement of the connector features 429 and thus thecover 421 and base 422 with respect to each other. As mentioned withrespect to device 100, in other variations, slots 430 may comprisegrooves or other structures providing a reduced thickness relative tothe cover 421 and base 422. The device 420 may include a releasemechanism as described with respect to FIGS. 1A-22B herein. The device420 may be used in the same manner as the devices described withreference to FIGS. 1A to 22B herein and may attach a dressing in thesame manner as described with respect to devices described withreference to FIGS. 1A to 22B herein.

The various structures, e.g. the segments and/or the cover and base andcoupling elements, slots and grooves may provide a structural support aswell as flexibility for the dressing carrier to be manipulated by auser. Margins between at least a portion of the structural supportelements, dressing carrier or backing and an attached dressing may beprovided at or near edges 421 a, 423 a, 424 a, 422 a, 425 a, and/or 426a, for example as described further herein.

FIG. 14 illustrates an alternative packaging or applicator device 520that may be used in any of the devices described herein with referenceto FIGS. 1A to 22B. A cover portion 521 and a dressing carrier or baseportion 522 may be constructed of a laminate structure 530. A firstlayer 531 of the laminate structure 530 comprises a paperboard or othersupport material such as a plastic material or metal having slots 528formed widthwise across each of the cover 521 and base 522. The slots528 form segments 527 that permit flexion of segments 527 of the device520 allowing it to conform to a subject's body contours where anattached dressing is to be applied. The first layer 531 furthercomprises lengthwise slot 529 between the cover 521 and base 522 formedin the first layer 531. The first layer 531 further comprises tabs 540with openings that are used in assembly of the device 520 and areremoved after assembly so that the cover 521 and base 522 are separatedby slot 529 and are no longer connected by the first layer 531. Thesecond layer 532 of the laminate comprises an adhesive material such asa PSA acrylic, rubber or silicone adhesive. The second layer 532 may ormay not be about 0.001 to 0.006 thick. A flexible strip 534 of materialis positioned along the length of the device 520 over the slot 529 andconnecting the cover 521 and base 522. The cover 521 and base 522 areflexibly and hingedly or pivotably coupled and moveable with respect toeach other by way of the strip 534 of material over the slot 529 topermit flexion or movement of the cover 521 and base 522 with respect toeach other. The flexible strip 534 is attached with an adhesive 535 to athird layer 533 that comprises a thin material such as paper or plasticthat may have generally a similar outline as the first layer 531 andthat holds the structure of the device 520, including segments 527,together.

The device 520 may include a release mechanism, dressing attachment andmay be used in the same manner devices and assemblies as described withrespect to FIGS. 1A-22B herein.

The various structures, e.g. the segments, adhesive structures, laminatelayers and/or the cover and base and coupling elements, slots andgrooves may provide structural support as well as flexibility for thedressing carrier, to facilitate manipulation by a user. Margins betweenat least a portion of the structural support elements, dressing carrieror backing and an attached dressing may be provided at or near edges 521a, 523 a, 524 a, 522 a, 525 a, and/or 526 a, for example as describedfurther herein.

Referring to FIGS. 15A to 15J, a variation of a dressing and packagingassembly 600 is illustrated. The packaging assembly 600 comprises anapplicator and/or tensioning device 620 and a dressing assembly 610including a dressing 630. The dressing 630 comprises an elastic sheet631, with one or more adhesive regions comprising a layer of skinadhesive such as described herein.

The features in FIGS. 15A to 15J may be used in any of the variationsherein including device elements or features that may being substitutedfor device elements or features of devices and assemblies shown in FIGS.1A to 22B.

The packaging assembly 600 applicator, tensioning device 620 and/ordressing assembly 610 may be configured to pre-strain the dressing 630and/or permit transfer of the pre-strained dressing 630 to the skin of asubject. The applicator or tensioning device 620 may also provide for aconvenient sterile transfer of an adhesive portion of the dressing to askin and/or wound site of a subject.

The device 620 comprises a cover 621 and a base 622. The dressingassembly 610 is removably coupled or anchored to the device 620 whichmay act as a dressing carrier. The cover 621 may be generally planar andinclude sides 623, 624 with corresponding edges 623 a and 624 b definingits length and edges 621 a at opposing ends. The base 622 may begenerally planar and include sides 625, 626 with corresponding edges 625a and 626 a defining its length and edges 622 a at opposing ends.

According to some variations, the cover 621 and/or base 622 or elementsor segments thereof may be constructed to be sufficiently firm or rigidor less flexible relative to an attached dressing to support an attacheddressing until it is applied to a subject as described with respect tothe variations herein. The materials and construction of the applicatoror tensioning device 620, dressing 630 and packaging 600 may be ofsimilar to the packaging assemblies and/or dressings described invariations herein and shown in FIGS. 1A to 22B.

The cover 621 and base and 622 may be movably, pivotably, bendably orhingedly coupled at sides 623, 624. For example, a layer of material 627such as silicone, polyurethane, low-density polyethylene or a rubbermaterial may be glued to each of the cover and base, flexibly attachingthem together at sides 623, 625. The device 620 may be constructed in amanner similar to that described with respect to other devices hereinand shown in FIGS. 1A to 22B and may be constructed in a similar manneras described herein including but not limited to with respect tomaterials, segmentation, strength and flexibility, visualization,straining mechanisms, and release liners.

The dressing assembly 610 also includes an attachment sheet 641,attachment sheet 651. The attachment sheet 641 has a first side 643 thatis attached to the second side 634 of the dressing by way of an adhesivestructure 670 such as polyimide film or tape (e.g. KAPTON® by DuPont™)or a peelable adhesive. Adhesive structures herein may include but arenot limited to KAPTON® tape or peelable adhesive configured to providelow skin trauma after repeated skin contact or a soft skin adhesive,made of material such as silicone adhesive, silicone gel, or acrylicadhesive. The adhesive structure or KAPTON® tape also comprises amaterial that is able to adhere to the attachment sheets to impartstrain to the dressing when the attachment sheets are separated fromeach other, while being peelable from a selected dressing material.

As shown in FIG. 15J, the attachment sheet 641 and side 634 of thedressing may be attached on same side 671 of the adhesive structure 670with the attachment sheet 641 overlapping but unattached to the dressing631.

The attachment sheet 641 has a second side 644 that is coupled to thecover 621 of the device 620 for example, by bonding with a low surfaceenergy PSA, such as an acrylic adhesive. Attachment sheet 641 may alsohave a score or perforation 681 between its attachment to the adhesivestructure 670 and its attachment to the cover 621. After the dressinghas been strained, the perforation 681 is located at the seam betweenthe cover 621 and the base 622, or over the inside surface of the cover621.

The attachment sheet 651 may be coupled at its side 654 to the back side698 of the base 622 for example, by bonding with a low surface energyPSA, such as an acrylic adhesive. The side 653 of attachment sheet 651may be attached to the side 633 of the dressing by way of an adhesivestructure 680 such as KAPTON® tape or a peelable adhesive, and in amanner similar to the adhesive structure 670 that attaches the side 654of the dressing 630 to the attachment sheet 641. The attachment sheet651 may include a pull tab 688 that is located on the back side 698 ofthe base adjacent and inside of the attachment zone 655 of theattachment sheet 651 to the back of the base 652.

The cover 621, when opened, exerts a straining force on the dressing 630through the attachment sheet 641.

According to some variations, the attachment sheets 641, 651 areflexible while being relatively inelastic with respect to the dressing630 and may be constructed, e.g., out of a low density polyethylene. Theattachment sheets 641, 651 may be manufactured to be tearable along thematerial length while providing tensile strength in other directions, inparticular in the tensioning direction of the material of the attachmentsheet 641 (direction in which dressing is tensioned, stressed orstrained). An example of such material is an LDPE polymer which isproduced by an extrusion process that creates an anisotropic ordirectionally biased grain whereby the material is tearable with thedirection of the grain, but has a relative resistance to tearing in thedirection transverse to the grain.

FIG. 15A shows the assembly 600 in an unstrained configuration. Anadhesive tape 683 is exposed on the inside surface 694 of the base 622.A skin adhesive layer on the elastic sheet 631 of the dressing 630 maybe protected by a release liner similar to release liner 149 a hereinbefore the applicator or tensioning device 620 is opened

FIG. 15B shows the assembly 600 in an opened and strained configuration.As shown in FIG. 15B, when strained, the perforation 681 on theattachment sheet is aligned with the edges 623 a and 625 a of the cover621 and base 622, respectively. A portion 641 a of the attachment sheet641 interfaces with the adhesive tape 683 attaching portion 641 a to thebase 622 and holding the dressing 630 in the strained configuration. Arelease liner 645 is attached to the underside of the attachment sheet641 between the attachment to the cover 621 and the perforation 681. Theliner 645 prevents the portion of the attachment sheet 641 thatinterfaces the cover 621 from adhering to the adhesive tape 683.

The cover 621 and base 622 may be separable from each other by way of,for example, a perforation 682 in the layer 627 that couples the cover621 to the base 622 and by separation of the sheet 641 along perforation681. FIG. 15C shows the assembly 600 with the cover 621 separated fromthe base 622. The strained dressing 630 may be applied to a subject'sskin using the base 622 as an applicator.

FIG. 15D illustrates the back side 698 of the base 622 in a position ofapplying the dressing 630 toward the skin of a subject. As shown, theedge 654 of attachment sheet 651 may be wrapped around from the inside694 of the base 622 to the back side 698 where it is attached. A tearstrip may be attached to the attachment sheet 651 between the attachededge and an unattached middle section. The pull tab 688 or tear stripmay be pulled to detach the base 622 from the remainder of the dressingassembly as shown in FIG. 15E. After the tab 688 is pulled, anunattached portion 651 a of the attachment sheet 651 is freed from thebase 622. After the base is removed, the remaining portions of theattachment sheets 641, 651 may be removed by peeling the KAPTON® tapeoff of the dressing 630. FIG. 15F shows the dressing 630 after removalof the remainder of the dressing assembly.

FIGS. 15G to 15J illustrate a configuration of the dressing assembly 610as the KAPTON® tape or adhesive structures 670, 680 and attachmentsheets 641, 651 are removed from the dressing 630. FIGS. 15G and 15Jshow the orientation of the KAPTON® tape or adhesive structures 670, 680as they are peeled in a direction from inside the dressing 630 towardsthe sides 633, 634 of the dressing 630, or in a direction of dressingstrain. FIG. 15H shows the first structure 670 peeled away from theinside of the dressing across the side 633 of the dressing. FIG. 15Ishows the first adhesive structure 670 removed from the dressing 630.The second adhesive structure 680 may be removed in a similar manner.

FIGS. 16A to 16D illustrate an alternative dressing assembly 710 in aconfiguration in which a dressing assembly 710 is separated from theapplicator or tensioning device in a manner similar to that describedwith respect to FIGS. 15A to 15J. FIG. 16A illustrates a first adhesivestructure 770 and a second adhesive structure 780, each comprisingKAPTON® tape or a peelable adhesive structure used to attach attachmentsheets 741, 751 to the dressing 730, As shown in FIG. 16A the unattachedends of the adhesive structures 770, 780 are oriented away from thedressing 730. As shown in FIG. 16B, the second adhesive structure 780 ispeeled inwardly and in FIG. 16C, is removed.

FIGS. 17A to 17D illustrate an alternative dressing assemblyconfiguration in which a dressing assembly 810 is separated from theapplicator or tensioning device in a manner similar to that describedwith respect to FIGS. 15A to 15J. FIG. 17D illustrates a first adhesivestructure 870 and a second adhesive structure 880, each comprisingKAPTON® tape or a peelable adhesive structure used to attach attachmentsheets 841, 851 respectively to the dressing 830. As shown in FIGS. 17Aand 17D, the adhesive structures 870, 880 are attached to the dressing830 with adhered length 891. An additional length 892 is wrapped 180degrees about the adhered length 891. The additional length 892 has anend 893 that extends proud of the dressing 830 for easy access andremoval. As shown in FIG. 17B, the first adhesive structure 870 may bepulled using the end 893, in a direction that is in part perpendicularto the direction of strain, to remove the attachment structures 841, 851and adhesive structure 870 from the dressing 830 as further shown inFIG. 17C.

FIGS. 18A to 18I illustrate a variation of a dressing and packagingassembly 900. The packaging assembly 900 comprises an applicator and/ortensioning device 920 and a dressing assembly 910 including a dressing930. The device 920 comprises a cover 921 and a base 922. The dressingassembly 910 is removably coupled or anchored to the device 920 whichmay act as a dressing carrier. The cover 921 may be generally planar andinclude sides 923, 924 with corresponding edges 923 a and 924 a definingits length and edges 921 a at opposing ends. The base 922 may begenerally planar and include sides 925, 926 with corresponding edges 925a and 926 a defining its length and edges 922 a at opposing ends.

The dressing assembly 910 also includes an attachment sheet 941 andattachment sheet 951. The attachment sheet 941 has a first side 943 thatis attached to the second side 934 of the dressing by way of an adhesivestructure 970 such as KAPTON® tape or a peelable adhesive. Adhesivestructures herein may include but are not limited to KAPTON® tape orpeelable adhesive configured to provide low skin trauma after repeatedskin contact or a soft skin adhesive, made of material such as siliconeadhesive, silicone gel, or acrylic adhesive. The adhesive structure orKAPTON® tape also comprises a material that is able to adhere to theattachment sheets to impart strain to the dressing when the attachmentsheets are separated from each other, while being peelable from aselected dressing material.

As shown in FIG. 18J, the attachment sheet 941 and side 934 of thedressing are attached on same side 971 of the adhesive structure 970with the attachment sheet 941 overlapping but unattached to the dressing931. The attachment sheet 941 has a second side 944 that is coupled tothe cover 921 of the device 920 for example, by bonding with a lowsurface energy PSA such as an acrylic adhesive. Attachment sheet 941 mayalso have a pull tab 981 in an unattached region between the attachmentto the adhesive structure 970 and attachment to the cover 921. After thedressing has been strained, the perforation pull tab 981 is located atthe inside surface 960 of the cover 921 or alternatively at the seambetween the cover 921 and the base 922.

The attachment sheet 951 is coupled at its side 954 to the back side 998of the base 922 for example, by bonding with a low surface energy PSAsuch as an acrylic adhesive. The side 953 of attachment sheet 951 isattached to the side 933 of the dressing 930 by way of an adhesivestructure 980 such as KAPTON® tape or a peelable adhesive, and in amanner similar to the adhesive structure 970 that attaches the side 944of the dressing 930 to the attachment sheet 941. The attachment sheet951 may include a pull tab 988 that is located on the back side 998 ofthe base adjacent and inside of the attachment zone 955 of theattachment sheet 951 to the back of the base 952.

According to some variations, the attachment sheets 941, 951 areflexible while being relatively inelastic with respect to the dressing930 and may be constructed, e.g., out of a LDPE. The attachment sheets941, 951 may be manufactured to be tearable along the material lengthwhile providing tensile strength in other directions, in particular inthe tensioning direction of the material of the attachment sheet 941(direction in which dressing is tensioned, stressed or strained). Anexample of such material is an LDPE polymer which is produced by anextrusion process that creates an anisotropic or directionally biasedgrain whereby the material is tearable with the direction of the grain,but has a relative resistance to tearing in the direction transverse tothe grain.

The cover 921, when opened, exerts a straining force on the dressing 930through the attachment sheet 941. FIG. 18A shows the assembly 900 in anunstrained configuration, while FIG. 18B shows the assembly 900 in anopened and strained configuration which may be applied to the skin. Asshown in FIG. 18C, when strained, the tab 981 on the attachment sheet941 is located over the inner surface of the cover 921 (folded back andexposed) and is accessible to a user. After applying the dressing 930,the cover 921 and base 922 may be removed.

The cover 921 and base 922 are separable from each when the tab 988 ispulled. FIG. 18C shows the assembly with the cover positioned with thedressing face down for example as it would be when applied to the skinof a subject. As shown in FIG. 18D the tab 988 is pulled to release thecover 921 from the remaining dressing assembly 910. As shown in FIG. 18Ethe cover 921 is removed from the remainder of the device 920, exposingthe second pull tab 998. As shown in FIG. 18F, the second pulled tab 998has released the base 922 from the dressing assembly 910 with attachmentsheets 941, 951 unattached to the base 922. As shown in FIG. 18G, thebase 922 is removed and the remainder of the attachment sheets 941, 951and the adhesive structures 970, 980 may be peeled away from thedressing 930 as shown if FIG. 18H with the dressing remaining on theskin in a configuration as shown in FIG. 18I.

Referring to FIGS. 19A through 19D, a variation of a dressing andpackaging assembly 1000 is illustrated. The packaging assembly 1000comprises an applicator and/or tensioning device 1020 and a dressingassembly 1010 including a dressing 1030. FIG. 19A shows the dressingassembly 1010 coupled to the applicator or tensioning device 1020. Thetensioning member or applicator 1020 may be constructed in a similarmanner as the tensioning and applicators described herein and shown inFIGS. 1A to 22B.

The device 1020 comprises a cover 1021 and a base 1022. The dressingassembly 1010 is removably coupled or anchored to the device 1020 whichmay act as a dressing carrier. The dressing assembly may be attached tothe tensioning member or applicator in a manner similar to theassemblies described herein. The dressing assembly 1010 includes anattachment sheet 1041 and attachment sheet 1051. The attachment sheet1041 has a first side 1043 that is attached to the second side 1034 ofthe dressing 1030 by way of an adhesive structure 1070 such describedwith reference to adhesive structures 970, 980. The attachment sheet1041 has a second side 1044 that is coupled to the cover 1021 of thedevice 1020 for example, by bonding with a low surface energy PSA suchas an acrylic adhesive. Attachment sheet 1041 also has a ripcord 1088stitched along its length at an unattached portion of the attachmentsheet 1041, between its attachment to the adhesive structure 1070 andattachment to the cover 1021. Various types of stitches may be usedincluding but not limited to a chainstitch or a lockstitch. After thedressing has been strained, the ripcord 1088 is located at the exposedinner side 1090 of the cover 1021 or alternatively at the seam betweenthe cover 1021 and the base 1022.

The attachment sheet 1051 is coupled at its side 1054 to the back sideof the base 1022 for example, by bonding with a low surface energy PSAsuch as an acrylic adhesive. The side 1053 of attachment sheet 1051 isattached to the side 1033 of the dressing by way of an adhesivestructure 1080 such as KAPTON® tape or a peelable adhesive, and in amanner similar to the adhesive structure 1070 that attaches the side1034 of the dressing 1030 to the attachment sheet 1041. The attachmentsheet 1051 includes a ripcord 1098 that is located between attachment tothe adhesive structure 1090 and attachment to the back of the base. Theends of the ripcords 1088, 1098 extend out of the tensioning member 1020for easy accessibility.

FIGS. 19A and 19B illustrate the dressing assembly 1010 in an unstrainedconfiguration. The cover 1021, when opened, exerts a straining force onthe dressing 1030 through the attachment sheet 1041. FIG. 19Cillustrates the dressing assembly 1010 in a strained configuration.

After the dressing is strained and applied, the ripcords 1088, 1098 arepulled to separate the portion of the attachment sheets 1041, 1051attached to the tensioning device 1020 from the portions of theattachment sheets 1041, 1051 attached to the dressing 1030. Theapplicator or tensioning device 1020 may then be removed as shown inFIG. 19D. The adhesive structures 1080, 1090 may then be peeled away toremove the remaining portion of the dressing assembly 1010 andattachment sheets 1041, 1051, from the dressing as shown in FIG. 19E.

Referring to FIGS. 20A to 20C, a variation is shown of a dressingcarrier, tensioning device or applicator 1120. The device 1120 comprisesa plurality of segments 1130 formed by scoring a substrate 1150 on oneside 1155 of a planar surface. The scores 1170 may be formed in one ormore directions or having one or more shapes, curved or straight.Additionally the scores may be formed on both sides permitting bothconvex and concave shaping of a device. As illustrated, the scores 1170permit shaping of the device or an attached dressing. The scores 1170 asillustrated are formed on a first side 1155 of a planar surface of thedevice while the second side 1165 is not scored. When a force is appliedto the second side 1165, the substrate bends. When a force is applied tothe first side 1155, the substrate 1150 the device does not flex at thescores 1170. The remaining substrate at the scores 1170 may act asflexion limiter while the scores 1170 act as a flex element.

When a convex dressing shape is desired for a concave surface, thedressing may be attached on the first side 1155 so that when thesubstrate is bent, the dressing forms a convex shape to match a concavecontour where the device is to be applied. When a concave dressing shapeis desired for a convex body contour, the dressing may be positioned onthe second side 1165 of the substrate 1150. So that when the substrateis bent, the dressing forms a concave shape to match a convex bodycontour where the device is to be applied. Various dressing backings maybe provided for different body locations or contours.

According to variations, the score may be orthogonal or have orthogonalcomponents with respect to the segments 1127 of the carrier, applicatoror tensioning device. The segments 1127 may be similar to segments shownin FIGS. 1A to 22B.

Referring to FIGS. 21A to 21D, a variation is shown of a dressingcarrier, tensioning device or applicator 1220. The device 1220 comprisesa plurality of foam cells 1240 coupled by and adhesive backing 1260. Thefoam cells 1240 form a plurality of segments 1227 that permit flexing inmultiple directions so that the device conforms to a curvature, profileor shape of a subject where the dressing is to be applied. The foam maybe sufficiently thick to generally provide added column strength forstraining a dressing. i.e. a resistance to bending. A backing or supportmay be provided for straining a dressing, for example constructed of amaterial with an elastic modulus and appropriate thickness that will, atminimum, counteract the force created by straining the dressing. Thedressing strain may be fixed, for example, using an adhesive on the backof a portion of the dressing assembly or attachment sheet. After thedressing is fixed, the backing or support may be removed permittingincreased manipulation of the shape of the strained dressing to conformto a greater degree to the shape of the patient's body contours wherethe dressing is to be applied.

As illustrated, the separations 1270 between the foam sections permitshaping of the device. The separations 1270 as illustrated are formed ona first side 1255 of a planar surface of the device while the secondside 1265 is not scored. When a force is applied to the first side 1255,the substrate bends. When a force is applied to the second side 1265,the substrate 1250 the device does not flex at the separations. Theremaining substrate at the separations may act as flexion limiter whilethe scores act as a flex element.

When a convex dressing shape is desired for a concave surface, thedressing may be attached on the first side 1255 so that when thesubstrate is bent, the dressing forms a convex shape to match a concavecontour where the device is to be applied. When a concave dressing shapeis desired for a convex body contour, the dressing may be positioned onthe second side 1265 of the substrate 1250. So that when the substrateis bent, the dressing forms a concave shape to match a convex bodycontour where the device is to be applied. Various dressing backings maybe provided for different body locations or contours.

Referring to FIGS. 22A and 22B, a variation of a dressing and packagingassembly 1500 is illustrated. The packaging assembly 1500 comprises anapplicator and/or tensioning device 1520 and a dressing assembly 1510including a dressing 1530. The packaging assembly 1500, applicator ortensioning device 1520, and/or dressing assembly 1510 may be configuredto pre-strain the dressing 1530 and/or permit transfer of thepre-strained dressing 1530 to the skin of a subject.

The device 1520 may comprise a cover 1521 and a base 1522. The dressingassembly 1510 is removably coupled or anchored to the device 1520, andmay serve as a dressing carrier. The cover 1521 and base 1522 aremovably, pivotably, bendably or hingedly coupled at side regions 1523,1524 and may be constructed in a manner similar to that described withrespect to covers and bases described in FIGS. 1A to 22B. Attachmentregions 1541, 1551 of the dressing assembly 1510 are attached near freesides 1525, 1526 of cover 1521, and base 1522 respectively, for exampleby way of a peelable adhesive or removable adhesive structures. Howeveran attachment sheet or attachment structure described with respect FIGS.1A to 22B herein may be used. The attachment regions 1541, 1551 and orpositioning of the dressing 1530 on the device 1520, may be symmetricwith respect to a line defined by attachment of side regions 1523, 1524of the cover 1521 and base 1522 respectively. As shown in FIG. 22B, thedressing 1530 is strained when the cover 1521 and base 1522 are opened.The dressing 1530 may then be applied to the skin of a subject and thedevice 1520 may be peeled away from the dressing 1530. In addition oralternatively, the cover 1521 and base 1522 may be separated by way of aperforation formed in the substrate of the device 1520 or a perforation1552 formed in an attachment structure 1550 such as a tape or layer ofmaterial that attaches side regions 1523 and 1524 of the cover 1521 andbase 1522 respectively.

In some variations, the device 1520 may optionally comprise an adhesivecoating or adhesive tape on the cover 1521 and/or base 1522 which mayadhere to the dressing 1530 when the dressing 1530 is tensioned and thedressing comes in further contact with the cover 1521 and base 1522. Insome variations, the adhesive is configured to maintain the dressing1530 in a tensioned state and/or against the cover 1521 and/or base1522. The adhesive coating or adhesive tape may be located along theside regions 1523, 1524 of the cover 1521 and/or base 1522, but may alsobe provided adjacent to the attachment regions 1541, 1551. Releaseliners may also be provided to reduce inadvertent adhesion of thedressing or other structures to the adhesive until activation of thedevice 1520 is desired.

According to variations, the various assemblies or devices describedherein may provide a temporary wound dressing that may be applied beforea wound is closed. The assembly may be configured to apply a dressing toa wound and to use the packaging or applicator to apply pressure to thewound before removing or separating the applicator, tensioning device ordressing carrier, base or support from the dressing. According to thisvariation, which may be provided with any of the embodiments describedbelow, the packaging or applicator has sufficient rigidity to distributea relatively even or firm force to a wound by applying pressure to thepackaging or applicator when and/or after the dressing is applied to awound. According to a variation, such dressing may include a coagulationagent or other agent or medicament, for example as described herein.According to another variation, margins as described herein, areprovided on such a device between a dressing and edges used tomanipulate the device.

The assemblies or devices described herein may also form a dressingsupport structure. For example, the dressing support structure maycomprise of a plurality of segments of the base structures. The dressingsupport structure may comprise at least 3 segments that extend at leastfrom a first side of the dressing to a second side of the dressing. Thedressing support structure may comprise a plurality of segments such assegments described in FIGS. 1A to 22B that are coupled or formedtogether. The plurality of segments of a cover described herein may alsoprovide support to a dressing when the cover is folded over 360 degreeswith respect to the corresponding base structure.

It is hypothesized that in some patients and/or uses of thetensile-stressed treatment devices, skin irritation along or near theedges and corners of the device may occur. It is further hypothesizedthat at or near the edges of a tensile stressed dressing applied to theskin, there may be intercellular debonding due to in part to aconcentration of localized traction forces that the dressing isimparting to the skin. Forces in the skin come from inherent stresses,physiological stresses due to motion, and the stresses imparted by thedevice. The traction forces imparted to the skin from the dressing maybe, e.g., a combination of shear, moment, and/or tensile forces. It ishypothesized that the intercellular forces can be viewed as the forcesholding the skin together that, when exceeded, may disrupt intercellularbonds and may result in a breach in the “protective function” of thestratum corneum of the skin. This breach may lead to mechanicalinflammation or the skin, and may serve as an entry to increasedbacterial colonization or infection. The various traction forces may actto varying degrees or in different amounts at different locations on theskin with respect to the location of the dressing on the skin. Forexample, it is further hypothesized that the shear forces of thedressing acting to compress skin under the dressing may tension the skinthat is outside and adjacent to or spaced from the dressing edge. It isfurther hypothesized that moment forces near the dressing edge mayimpart forces to the skin at or immediately adjacent the edge of thedressing. Without desiring to be bound by any particular theory, it isbelieved that redistributing the traction forces exerted on the skin ator adjacent to the edges of a tensile stressed dressing applied to theskin may reduce peak stress seen at or adjacent to the edges to a levelthat is below the intracellular forces which act to bond the skin layerin the location of ad adjacent to the dressing on the skin, and thus mayreduce skin irritation or bacterial entry. In some variations, geometricfeatures located within the plane of the dressing may be provided on aborder of a dressing to reduce peak stresses seen at the dressing edges,compared to straight dressing edges. It is hypothesized that with agiven tensioned dressing, while the same total amount of traction forcesmay be applied by the dressing to a skin location, the localized forcesmay be distributed in a manner that reduces average peak forces seen ator adjacent to the edges of the dressing.

Without desiring to be bound by any particular theory, it ishypothesized that effectively increasing the compliance at the edges ofa dressing may reduce peak forces seen near the edges. It is furtherhypothesized that reducing the overall dressing area in a modulationzone or at an edge of a dressing may increase the effective complianceof the dressing in the modulation zone. It is further hypothesized thatselecting or providing various geometrical features of edge extensionsmay reduce peak forces seen at or near the edges of the dressing. It isfurther hypothesized that increasing the length of the edge whilemaintaining a relatively small radius of curvature may reduce localizedpeak forces seen at or near edges of the dressing.

FIG. 25 depicts a schematic cross section of a dressing 4000 applied tothe stratum corneum of the skin 4100. The dressing 4000 may imparttraction forces to the stratum corneum of the skin 4200 that isunderneath the dressing 4000 at or near the edge 4300 of the dressing4000, and/or a tensile forces at a location 4400 outside the dressingskin interface.

FIGS. 26A and 26B schematically illustrate a simplified hypotheticaldistribution of average shear forces on the stratum corneum of the skinalong a portion of a width of a portion of the side or edge of adressing 5000. FIG. 26B illustrates a graph, in alignment andcorresponding with dressing 5000 depicted in FIG. 26A, depicting themagnitude of average shear stress acting on the skin as a function ofpositional distance from the edge 5200 of the dressing wherein thedressing edge is oriented transverse to the tensile axis of thedressing. Average shear stress curve A FIG. 26B schematically depictsthe hypothetical average shear force distribution of a dressing withstraight edges.

FIGS. 27A and 27B schematically illustrate a simplified hypotheticaldistribution of average shear forces on the stratum corneum of the skinalong a portion of a width of a portion of the side or edge 6200 of adressing 6000. FIG. 27B illustrates a graph, in alignment andcorresponding with dressing 6000 depicted in FIG. 27A, depicting themagnitude of average shear stress acting on the skin as a function ofpositional distance from the edge 6200 of the dressing wherein thedressing edge is oriented transverse to the tensile axis of thedressing. Average shear stress curve FIG. 27B schematically depicts thehypothetical average shear force distribution of a dressing 6000 with amodulation zone 6250 having geometrical extensions 6280.

For comparative purposes, it is assumed that force curves A and B havethe same total or net amount of force (e.g., the area under theirrespective curves) provided by dressing A and dressing B on the skin,and that hypothetical intercellular force, F_(i) is found between thecells of the skin 4100 (FIG. 25). For dressing A, the hypotheticalaverage peak shear stress τ_(a), translated to the skin exceed theintercellular forces F_(i) at some points along the edge or adjacent theedge of the dressing. The same amount of average force translated to theskin is distributed differently with dressing B which translates anaverage peak shear stress τ_(b) adjacent to the dressing edge which doesnot exceed the intercellular forces in the stratum corneum of the skinin the treatment zone in at least one location or some locations alongthe edge or adjacent to the dressing edge. Specifically it is believedthat relative to the average peak shear stress τ_(a) of dressing A, theaverage peak shear stress τ_(b) of dressing B is relatively lower inmagnitude and located relatively farther from the edge of the dressing5000, 6000, and the shape of the force curve of dressing B may or maynot be relatively wider than the force curve of dressing A. Put anotherway, the mean and the median of dressing B is closer than the mean andthe median of dressing A, over a dressing or skin region thatencompasses the average peak shear forces τ_(a) and τ_(b) of bothdressings A and B. In some variations, the average peak shear stressτ_(b) of dressing B is relatively lower than the average peak shearstress τ_(a) of dressing A by at least 5%, at least 10%, at least 20%,at least 25%, at least 30%, at least 35%, or at least 40% or more. Insome variations, the distance from the edge of the dressing for averagepeak shear stress τ_(b) is greater than the distance from the edge ofthe dressing for peak force τ_(a), by at least about 20%, 40%, 60%, 80%,100%, 120%, 140%, 160%, 180% or 200%. These parameters may be variedbased upon the features of the modulation zone described below, e.g. theamplitude, wavelength, dressing, open areas, frequency, radii ofcurvature, and shape, in addition to dressing material, thickness,modulus of elasticity, location or distance from original strainimparted to dressing prior to application, load per width of stresseddressing, and in some variations, these parameters may be limited by thelarger size of the dressing configured to achieve relatively greaterlowering of the peak force τ_(b) or greater distance from the edge ofthe dressing for peak force τ_(b).

FIGS. 23A and 23B schematically illustrate an exemplary dressing 2000that may be constructed in a manner similar to dressings describedherein. In addition, the dressing 2000 includes a modulation zone 2500configured to distribute edge stresses, or otherwise provide a means forreducing peak edge stresses. The modulation zone may comprise aplurality of geometrical extensions 2050 along at least a portion ofedges or sides 2200, 2300 of dressing 2000. The modulation zone 2500 mayfurther comprise cutouts or open spaces or areas 2310 between theextensions 2050. The geometrical extensions 2050 may comprise forexample, waveforms, undulating features, fingers or extensions. Amodulation waveform 2600 may have a wavelength 2650 and comprise aplurality of extensions 2050 having peaks 2110 and valleys 2120 thatdefine the cutout or open space or area 2310 between each of theextensions 2050. The extensions 2050 and open areas 2310, or thewaveforms 2600 may extend along at least a portion of the sides 2200,2300 of dressing 2000. The extensions 2050 and/or open areas 2310 mayextend along ends 2400 of dressing 2000 and may be offset a distanced_(c) from a centerline 2450 extending between and orthogonal to ends2400. Corners 2030 between ends 2400 and sides 2200, 2300 may berounded. The peak 2110 of extensions 2050 or a waveform 2600 may or maynot be at a peak 2110 p of the radius of curvature of a corner 2030.

Each of the edge extensions 2050 may have an amplitude 2710, a minimumgap 2770 orthogonally between edge extensions at greatest widths of edgeextensions, a minimum neck width 2720, a maximum neck width that may bethe same or different from the minimum neck width, a head radius 2730, aneck radius 2740 and a surface area (bound by a line of best fit throughthe base of the edge extensions). The open areas may each have a maximumwidth 2760 and a surface area. The modulation zone 2500 is defined bythe amplitude 2710 of each of the extensions 2050 and the width of thedressing 2000. In some variations, the base width or neck width of theextension is generally uniform along its length, except for the roundingor tapering at the distal end of the extension, but in other variations,as exemplified in FIGS. 24A to 24F, the extension may comprise anenlarged distal end that may be larger or otherwise different than theneck width. In addition to these characteristics for each individualedge extension, the undulating features described herein may also becharacterized by their average characteristics for the entire dressing,or over a certain edge length or dressing length, e.g. the one or twoedges that are orthogonal to the tension axis of the dressing. Thefeatures of the extensions may include an average amplitude, averageminimum neck width, average head radius, average neck radius and averagearea. The open areas may have an average minimum gap, an average maximumwidth and average area.

The extensions 2050 are typically oriented in-plane with the generalplanar orientation of the dressing, when the dressing is in an unbiasedstate. In other examples, however, the extensions may exhibit anundulating configuration that may comprise an out-of-plane component,relative to the general planar orientation of the dressing. Also, thegeometrical extensions 2050 on one side or edge of the dressing,relative to the features 2050 on an opposite side of the dressing, mayor may not be partially or completely symmetrical with respect to one ormore centerlines of the dressing, or otherwise aligned withcorresponding modulation features on the opposite side. In otherembodiments, the modulation features may be partially or completelyoffset relative to the opposite edge.

The various geometric edge features illustrated in exemplary FIGS. 23Ato 24F generally comprise semicircular peaks that do not have sharpedges or small radii of curvature (e.g. the minimum radii of curvaturemay be at least about 0.8 mm, 1 mm, or 2 mm, or 3 mm, or 4 mm, or 5 mmor more). It is hypothesized that a modulation zone with an edgeconfiguration comprising alternating oriented semi-circles may beoptimal under some conditions, which has an edge length that is 50%greater or more than a corresponding straight edge.

The geometric features provide a greater edge length versus a straightedge or curve of best fit tangential to the bases of the extensions andbases of the open areas. It is hypothesized that the greater edge lengthmay at least in part provide a more desirable distribution of forcesimparted to the skin. In some variations, the edge length of themodulation zone relative to the length of the straight edge/curve ofbest fit that includes at least two extensions and at least two relatedtroughs may be at least 50% greater, and in other embodiments is atleast 100% or even at least 150% greater. The ratio of the average edgelength of the modulation zone relative the length of the straightedge/curve of best fit that includes at least two extensions and atleast two related troughs may be at least 3:2 and in other embodimentsis at least 2:1 or at least 3:1.

In some variations, including but not limited to alternatingsemi-circles, the ratio of total extension surface area to total opensurface area may be about 1, as bound between the outer perimeter by astraight line or curve of best fit tangential through the distal mostedges of the extensions and the base perimeter by a straight line orcurve of best fit tangential through the proximal edge of the open areasand base of the extensions. In other variations, the ratio of the totalextension surface area to the total open surface area may be at least0.8, at least 0.9, at least 1, at least 1.1, at least 1.2, or about 0.9to about 1.1, or about 0.8 to about 1.2, or about 0.8 to about 1, orabout 1 to about 1.2.

In some variations the percent amplitude to total width may be about 12%to 35% and in some variations may be about 10% to 40%. In somevariations the average percent amplitude to total width may be about 12%to 35% and in some variations may be about 10% to 40%.

In FIG. 23B, the wavelength 2650 may be about 7.2 mm. The amplitude ofthe extensions 2050 may be about 5 mm. The neck width may be about 2 mm.The head radius may be about 1.6 mm. The neck radius may be about 1.6mm. The area of the extension may be about 18 sq mm. The minimum gap ofthe cutout 2310 may be about 2 mm. The area of the cutout may be about18 sq mm. The percent reduction of area of the modulation zone (% ofcutout area of the overall area of the modulation zone) may be about50%.

FIGS. 24A to 24F illustrate alternate configurations of geometricextensions.

In FIG. 24A, the wavelength 2650 a may be about 8 mm. The amplitude ofthe extensions 2050 a may be about 5 mm. The minimum neck width may beabout 2 mm. The head radius may be about 1.35 mm. The neck radius may beabout 2.13 mm. The area of the extension is about 12.6 sq mm. Theminimum gap of the open area 2130 a may be about 2 mm. The area of thecutout may be about 25.90 sq mm. The percent reduction of area of themodulation zone (% of cutout area of the overall area of the modulationzone) may be about 67%.

In FIG. 24B, the wavelength 2650 b may be about 6 mm. The amplitude ofthe extensions 2050 b may be about 5 mm. The minimum neck width may beabout 3.15 mm. The head radius may be about 2.00 mm. The neck radius isabout 0.84 mm. The area of the extension may be about 17.27 sq mm. Theminimum gap of the open area 2130 b may be about 2 mm. The area of thecutout may be about 12.73 sq mm. The percent reduction of area of themodulation zone (% of cutout area of the overall area of the modulationzone) may be about 42%.

In FIG. 24C, the wavelength 2650 c may be about 10 mm. The amplitude ofthe extensions 2050 c may be about 10 mm. The minimum neck width may beabout 2 mm. The head radius may be about 4.0 mm. The minimum neck radiusmay be about 1 mm. The area of the extension is about 55 sq mm. Theminimum gap of the open area 2130 c may be about 2 mm. The area of thecutout is 45 sq mm. The percent reduction of area of the modulation zone(% of cutout area of the overall area of the modulation zone) may beabout 45%.

In FIG. 24D, the wavelength 2650 d may be about 16 mm. The amplitude ofthe extensions 2050 d may be about 10 mm. The neck width may be about 2mm. The head radius may be about 4 mm. The neck radius may be about 1.0mm. The area of the extension may be about 55 sq mm. The minimum gap ofthe open area 2130 d may be about 8 mm. The area of the cutout may beabout 105 sq mm. The percent reduction of area of the modulation zone (%of cutout area of the overall area of the modulation zone) may be about66%.

In FIG. 24E, the wavelength 2650 e may be about 4.5 mm. The amplitude ofthe extensions 2050 e may be about 10 mm. The neck width may be about 2mm. The head radius may be about 1.25 mm. The neck radius may be about1.0 mm. The area of the extension may be about 23 sq mm. The minimum gapof the open area 2130 e may be about 2 mm. The area of the cutout may beabout 24 sq mm. The percent reduction of area of the modulation zone (%of cutout area of the overall area of the modulation zone) may be about51%.

In FIG. 24F, the wavelength 2650 f may be about 7.5 mm. The amplitude ofthe extensions 2050 f may be about 10 mm. The neck width may be about 2mm. The head radius may be about 1.25 mm. The neck radius may be about1.0 mm. The area of the extension may be about 20.6 sq mm. The minimumgap of the open area 2130 f may be about 5 mm. The area of the cutoutmay be about 52 sq mm. The percent reduction of area of the modulationzone (% of cutout area of the overall area of the modulation zone) maybe about 72%.

According to variations, the wavelength and/or average wavelength may bebetween 4.5 mm and 16 mm, or between 6 mm and 8 mm. The amplitude and/oraverage amplitude may be between 5 mm and 10 mm. The neck width oraverage neck width average minimum neck width may be about 2 mm or more.The head radius or average head radius may be about 1 mm to 4 mm or 1.2mm to 4 mm. The neck radius or average neck radius may be about 0.7 mmto 2.7 mm or 0.8 mm to 2.2 mm. The average area of the dressing 2000 maybe about 12 sq mm to about 16 sq mm. The average area may be more than16 sq mm or the average area may be less than 12 sq mm. The average cutout area may be about 14 sq mm to 105 sq mm. The average reduction ofdressing (or open area as a percentage of overall area of modulationzone area) in the modulation zone of a wavelength may be between about80% and 25% or between about 75% and 30% of the total area of themodulation zone. The average peak-to-peak distance and/or the averagetrough-to-trough may be about 5 mm to 9 mm.

The dressing 2000 may also comprise attachment structures 2900 in anattachment zones or regions 2950, for attaching a tensioning device tostrain the dressing between the attachment zones or regions 2950, forexample as described herein or in U.S. application Ser. No. 12/854,859,filed on Aug. 11, 2010 incorporated in its entirety herein by reference.There may be a distance dl between the application of a load by theapplicator and a cutout that may vary for example from 0 mm to 5 mm. Themodulation zones 2500 may also be offset from a centerline between ends2400.

While this invention has been particularly shown and described withreferences to embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and details may be madetherein without departing from the scope of the invention. For all ofthe embodiments described above, the steps of the methods need not beperformed sequentially.

The invention claimed is:
 1. A tissue treatment device, comprising: anelastic sheet, comprising: a planar skin interfacing surface; a firstundulating edge; and a second undulating edge farthest and opposite fromthe first undulating edge; wherein the elastic sheet further comprises afirst tensile stressed configuration and a second tensile stressedconfiguration; wherein the skin interfacing surface is configured toadhere to skin in the first tensile stressed configuration andconfigured to partially relax to the second tensile stressedconfiguration to compress the adhered skin; wherein the undulating edgesare configured to reduce localized tensile stresses at one or morelocations along the first undulating edge and the second undulatingedge; and wherein each undulating edge comprises at least twoconsecutive extensions each having a peak, an average amplitude, and aminimum separation of at least 2 mm between each extension and anaverage peak-to-peak distance that is equal to or less than twice theaverage amplitude.
 2. The device of claim 1, wherein each undulatingedge further comprises at least one of curved edge segments or straightedge segments, and wherein the first undulating edge and the secondundulating edge each lack sharp angles and sharp vertices.
 3. The deviceof claim 1, wherein the average amplitude of the first undulating edgeis at least 4 mm and is between about 10% and 40% of a distance betweenthe first undulating edge and the second undulating edge.
 4. The deviceof claim 3, wherein the average amplitude of the first undulating edgeis no more than 20 mm.
 5. The device of claim 1, wherein a ratio of theaverage amplitude and the average peak-to-peak distance is in a range ofabout ⅓ to about
 2. 6. The device of claim 5, wherein the ratio of theaverage amplitude and the average peak-to-peak distance is in the rangeof about 0.8 to about 1.2.
 7. The device of claim 1, wherein the elasticsheet further comprises a third undulating edge spanning between firstand second undulating edges and a fourth undulating edge spanningbetween the first undulating edge and second undulating edge farthestand opposite the third undulating edge.
 8. The device of claim 7,wherein the elastic sheet further comprises rounded corners between thefirst and third undulating edges, the first and fourth undulating edges,the second and third undulating edges and the second and fourthundulating edges, and wherein the minimum radius of curvature of therounded corners is at least 5 mm.
 9. The device of claim 7, wherein thethird undulating edge comprises at least three extensions and wherein aaverage peak-to-peak distance of the third undulating edge is differentfrom the average peak-to-peak distance of the first undulating edge orsecond undulating edge.
 10. The device of claim 1, wherein the at leasttwo consecutive extensions each comprises a neck with a minimumextension width located proximal to a distal end of the extension and ahead located distal to the neck and with a maximum extension width thatis larger than the minimum extension width.
 11. The device of claim 10,wherein each head comprises at least a semi-circular curved segment. 12.The device of claim 11, wherein each head comprises at least athree-quarters circular curved segment.
 13. The device of claim 10,wherein a minimum gap between each head is at least 2 mm.
 14. The deviceof claim 10, wherein a minimum gap between each neck is 5 mm.
 15. Thedevice of claim 10, wherein the minimum extension width is in a range ofabout 1.5 mm to about 5.5 mm.
 16. The device of claim 10, wherein theaverage amplitude of the first undulating edge is in a range of about 5mm to about 10 mm.
 17. A method of treating a patient, comprising:adhering an elastic sheet in a first stressed configuration to atreatment area, the elastic sheet comprising: a planar skin interfacingsurface; a first undulating edge; and a second undulating edge farthestand opposite from the first undulating edge; wherein the undulatingedges are configured to reduce localized tensile stresses at one or morelocations along the first undulating edge and the second undulatingedge; and wherein each undulating edge comprises at least twoconsecutive extensions each having a peak, an average amplitude, and aminimum separation of at least 2 mm between each extension and anaverage peak-to-peak distance that is equal to or less than twice theaverage amplitude; allowing the elastic sheet in the first stressedconfiguration to partially relax to a second tensile stressedconfiguration to compress the adhered skin.
 18. The method of claim 17,further comprising using an applicator device to stretch the elasticsheet from an unbiased configuration to the first stressedconfiguration.